ESSURE
Report
- Report Number
- 2951250-2019-01478
- Event Type
- Injury
- Date Received
- April 25, 2019
- Date of Event
- August 1, 2014
- Report Date
- April 24, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ('MIGRATED'), LARGE INTESTINE PERFORATION ('POKING INTO MY COLON'), EMBEDDED DEVICE ('MIGRATION OF ESSURE: OVARY/ MALPOSITION OF ESSURE/ HAD EMBEDDED ESSURE COIL/ MIGRATION OF ESSURE: EMBEDDED IN RIGHT UTERINE SIDEWALL BY THE OSTIUM, ROBOTIC ASSISTED EXCISION OF RIGHT EMBEDDED'), PELVIC PAIN ('PAIN'), MENORRHAGIA ('ABNORMAL BLEEDING ( MENORRHAGIA)') AND NEPHROLITHIASIS ('OTHER INJURY(IES) OR COMPLICATION PLEASE DESCRIBE: KIDNEY STONES') IN A 36-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. B04960-INV,804950) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED THYROID NODULAR, CERVICAL PAP SMEAR ABNORMAL, TUMMY TUCK, UTERINE BLEEDING, URETERAL CALCULUS, NEPHROLITHIASIS, VULVOVAGINAL HUMAN PAPILLOMA VIRUS INFECTION, ITCHING, BURNING SENSATION, IRRITATION EYE, BREAST TENDERNESS, GALACTORRHEA, ADHD, ANXIETY, DEPRESSION, PANIC DISORDER, METRORRHAGIA, HEMATURIA, FLANK PAIN, URETEROLITHIASIS, UROLITHIASIS, DIARRHEA, NAUSEA, VOMITING, DEPRESSIVE DISORDER, POST-TRAUMATIC STRESS DISORDER, ATTENTION DEFICIT/HYPERACTIVITY DISORDER AND ASTHMA. CONCOMITANT PRODUCTS INCLUDED ALPRAZOLAM (XANAX) SINCE (B)(6) 2016, BUPROPION HYDROCHLORIDE (WELLBUTRIN) SINCE (B)(6) 2016, CEFALEXIN (CEPHALEXIN AMEL), ESCITALOPRAM OXALATE (LEXAPRO), FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF), PARACETAMOL (ACETAMINOPHEN) AND PHENAZOPYRIDINE. ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2014, THE PATIENT EXPERIENCED INSOMNIA ("LACK OF SLEEP"), HOT FLUSH ("HOT FLASHES") AND MOOD ALTERED ("MOODINESS"), 1 MONTH 25 DAYS AFTER INSERTION OF ESSURE. ON (B)(6) 2014, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA"). ON (B)(6) 2014, THE PATIENT EXPERIENCED URINARY TRACT INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL), TYPE: URINARY TRACT INFECTION"). ON (B)(6) 2014, THE PATIENT EXPERIENCED MENTAL DISORDER ("PHYCOLOGICAL PROBLEMS OR CONDITION"). ON (B)(6) 2014, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("DYSMENORRHEA"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND FATIGUE ("FATIGUE"). ON (B)(6) 2015, THE PATIENT EXPERIENCED NEPHROLITHIASIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON (B)(6) 2015, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINE / HEADACHE"). ON (B)(6) 2018, THE PATIENT EXPERIENCED EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), LARGE INTESTINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN ("ABDOMINAL PAIN"), ABDOMINAL PAIN LOWER ("LOWER ABDOMINAL PAIN"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), DEPRESSION ("DEPRESSION"), ANXIETY ("ANXIETY") AND URINARY INCONTINENCE ("TROUBLE HOLDING YOUR BLADDER"). THE PATIENT WAS TREATED WITH IBUPROFEN AND SURGERY (ABLATION ON (B)(6) 2016 AND LAPAROSCOPIC REMOVAL OF ESSURE CLIPS WITH PARTIAL SALPINGECTOMY, ROBOTIC ASSISTED EXCISION OF RIGHT). ESSURE WAS REMOVED ON (B)(6)2018. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, LARGE INTESTINE PERFORATION, PELVIC PAIN, ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, DYSMENORRHOEA, NEPHROLITHIASIS, DYSPAREUNIA, VAGINAL DISCHARGE, FATIGUE, MENTAL DISORDER, DEPRESSION, ANXIETY AND URINARY INCONTINENCE OUTCOME WAS UNKNOWN AND THE EMBEDDED DEVICE, MENORRHAGIA, VAGINAL HAEMORRHAGE, URINARY TRACT INFECTION, MIGRAINE, INSOMNIA, HOT FLUSH AND MOOD ALTERED HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ANXIETY, DEPRESSION, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, EMBEDDED DEVICE, FATIGUE, HOT FLUSH, INSOMNIA, LARGE INTESTINE PERFORATION, MENORRHAGIA, MENTAL DISORDER, MIGRAINE, MOOD ALTERED, NEPHROLITHIASIS, PELVIC PAIN, URINARY INCONTINENCE, URINARY TRACT INFECTION, VAGINAL DISCHARGE AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED IN ESSURE DATE OF REMOVAL - (B)(6) 2016. DISCREPANCY NOTED IN DATE OF BIRTH- (B)(6) 1982. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): COMPUTERISED TOMOGRAM ABDOMEN - (B)(6) 2016: IMPRESSION: NO ACUTE ABNORMALITY. TINY PUNCTATE NON-OBSTRUCTIVE LEFT NEPHROLITHIASIS. NO OBSTRUCTIVE UROPATHY. STABLE 1.7 CM LEFT RENAL ANGIOMYOLIPOMA. CONSTIPATION STABLE APPEARANCE OF TUBAL LIGATION/STERILIZATION WITH INCOMPLETE VISUALIZATION OF THE LEFT STERILIZATION DEVICE. THIS COULD BE FURTHER EVALUATED WITH HYSTEROSALPINGOGRAPHY. HYSTEROSALPINGOGRAM - ON (B)(6) 2014: TOTAL BILATERAL OCCLUSION. MAGNETIC RESONANCE IMAGING ABDOMINAL - ON (B)(6) 2017: UTERUS: ACCURATE CONFIGURATION OF THE URETHRA. INTERSTITIAL OR INFUNDIBULAR LOCATION OF THE RIGHT TUBAL OCCLUSION DEVICE EXTENDING INTO THE ISTHMUS OR PROXIMAL TUBE, WITHOUT APPRECIABLE CHANGE IN LOCATION FROM PRIOR CT. SIGNAL DROP OFF ARTRACT (AS WRITTEN) FROM ESSURE WIRE OBSERVES ISTHAMIC SEGMENT. NO REGIONAL COLLECTIONS. NO EXTRA UTERINE OR EXTRA TUBAL MIGRATION.. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS : MENORRHAGIA, KIDNEY STONE, DYSMENORRHEA, ABDOMINAL PAIN MIGRAINE, MOOD SWINGS, PELVIC PAIN. LOT NUMBER REPORTED B04960 IS NOT VALID. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE WAS REPORTED VIA SOCIAL MEDIA: BLADDER INCONTINENCE MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2020: PFS RECEIVED : LOT NUMBER ADDED, EVENTS ONSET DATE ADDED. WE RECEIVED A LOT NUMBER IN THIS CASE. A TECHNICAL INVESTIGATION WILL BE CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER RELEVANT DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ('MIGRATED'), LARGE INTESTINE PERFORATION ('POKING INTO MY COLON'), EMBEDDED DEVICE ('MIGRATION OF ESSURE: OVARY/ MALPOSITION OF ESSURE/ HAD EMBEDDED ESSURE COIL/ MIGRATION OF ESSURE: EMBEDDED IN RIGHT UTERINE SIDEWALL BY THE OSTIUM, ROBOTIC ASSISTED EXCISION OF RIGHT EMBEDDED'), PELVIC PAIN ('PAIN'), MENORRHAGIA ('ABNORMAL BLEEDING ( MENORRHAGIA)') AND NEPHROLITHIASIS ('OTHER INJURY(IES) OR COMPLICATION PLEASE DESCRIBE: KIDNEY STONES') IN A 36-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. B04960-INV,804950-INV) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED THYROID NODULAR, CERVICAL PAP SMEAR ABNORMAL, TUMMY TUCK, UTERINE BLEEDING, URETERAL CALCULUS, NEPHROLITHIASIS, VULVOVAGINAL HUMAN PAPILLOMA VIRUS INFECTION, ITCHING, BURNING SENSATION, IRRITATION EYE, BREAST TENDERNESS, GALACTORRHEA, ADHD, ANXIETY, DEPRESSION, PANIC DISORDER, METRORRHAGIA, HEMATURIA, FLANK PAIN, URETEROLITHIASIS, UROLITHIASIS, DIARRHEA, NAUSEA, VOMITING, DEPRESSIVE DISORDER, POST-TRAUMATIC STRESS DISORDER, ATTENTION DEFICIT/HYPERACTIVITY DISORDER AND ASTHMA. CONCOMITANT PRODUCTS INCLUDED ALPRAZOLAM (XANAX) SINCE (B)(6) 2016, BUPROPION HYDROCHLORIDE (WELLBUTRIN) SINCE (B)(6) 2016, CEFALEXIN (CEPHALEXIN AMEL), ESCITALOPRAM OXALATE (LEXAPRO), FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF), PARACETAMOL (ACETAMINOPHEN) AND PHENAZOPYRIDINE. ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2014, THE PATIENT EXPERIENCED INSOMNIA ("LACK OF SLEEP"), HOT FLUSH ("HOT FLASHES") AND MOOD ALTERED ("MOODINESS"), 1 MONTH 25 DAYS AFTER INSERTION OF ESSURE. ON (B)(6) 2014, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA"). ON (B)(6) 2014, THE PATIENT EXPERIENCED URINARY TRACT INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL), TYPE: URINARY TRACT INFECTION"). ON (B)(6) 2014, THE PATIENT EXPERIENCED MENTAL DISORDER ("PSYCHOLOGICAL PROBLEMS OR CONDITION"). ON (B)(6) 2014, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("DYSMENORRHEA"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND FATIGUE ("FATIGUE"). ON (B)(6) 2015, THE PATIENT EXPERIENCED NEPHROLITHIASIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON (B)(6) 2015, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINE / HEADACHE"). ON (B)(6) 2018, THE PATIENT EXPERIENCED EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), LARGE INTESTINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN ("ABDOMINAL PAIN"), ABDOMINAL PAIN LOWER ("LOWER ABDOMINAL PAIN"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), DEPRESSION ("DEPRESSION"), ANXIETY ("ANXIETY") AND URINARY INCONTINENCE ("TROUBLE HOLDING YOUR BLADDER"). THE PATIENT WAS TREATED WITH IBUPROFEN AND SURGERY (ABLATION ON (B)(6) 2016 AND LAPAROSCOPIC REMOVAL OF ESSURE CLIPS WITH PARTIAL SALPINGECTOMY, ROBOTIC ASSISTED EXCISION OF RIGHT). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, LARGE INTESTINE PERFORATION, PELVIC PAIN, ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, DYSMENORRHOEA, NEPHROLITHIASIS, DYSPAREUNIA, VAGINAL DISCHARGE, FATIGUE, MENTAL DISORDER, DEPRESSION, ANXIETY AND URINARY INCONTINENCE OUTCOME WAS UNKNOWN AND THE EMBEDDED DEVICE, MENORRHAGIA, VAGINAL HAEMORRHAGE, URINARY TRACT INFECTION, MIGRAINE, INSOMNIA, HOT FLUSH AND MOOD ALTERED HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ANXIETY, DEPRESSION, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, EMBEDDED DEVICE, FATIGUE, HOT FLUSH, INSOMNIA, LARGE INTESTINE PERFORATION, MENORRHAGIA, MENTAL DISORDER, MIGRAINE, MOOD ALTERED, NEPHROLITHIASIS, PELVIC PAIN, URINARY INCONTINENCE, URINARY TRACT INFECTION, VAGINAL DISCHARGE, AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED IN ESSURE DATE OF REMOVAL - (B)(6) 2016. DISCREPANCY NOTED IN DATE OF BIRTH- (B)(6) 1982. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): COMPUTERISED TOMOGRAM ABDOMEN - ON (B)(6) 2016: IMPRESSION: NO ACUTE ABNORMALITY. TINY PUNCTATE NON-OBSTRUCTIVE LEFT NEPHROLITHIASIS. NO OBSTRUCTIVE UROPATHY. STABLE 1.7 CM LEFT RENAL ANGIOMYOLIPOMA. CONSTIPATION STABLE APPEARANCE OF TUBAL LIGATION/STERILIZATION WITH INCOMPLETE VISUALIZATION OF THE LEFT STERILIZATION DEVICE. THIS COULD BE FURTHER EVALUATED WITH HYSTEROSALPINGOGRAPHY. HYSTEROSALPINGOGRAM - ON (B)(6) 2014: TOTAL BILATERAL OCCLUSION. MAGNETIC RESONANCE IMAGING ABDOMINAL - ON (B)(6) 2017: UTERUS: ACCURATE CONFIGURATION OF THE URETHRA. INTERSTITIAL OR INFUNDIBULAR LOCATION OF THE RIGHT TUBAL OCCLUSION DEVICE EXTENDING INTO THE ISTHMUS OR PROXIMAL TUBE, WITHOUT APPRECIABLE CHANGE IN LOCATION FROM PRIOR CT. SIGNAL DROP OFF ARTRACT (AS WRITTEN) FROM ESSURE WIRE OBSERVES ISTHAMIC SEGMENT. NO REGIONAL COLLECTIONS. NO EXTRA UTERINE OR EXTRA TUBAL MIGRATION. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS : MENORRHAGIA, KIDNEY STONE, DYSMENORRHEA, ABDOMINAL PAIN MIGRAINE, MOOD SWINGS, PELVIC PAIN. LOT NUMBER REPORTED B04960 IS NOT VALID. THE LOT NUMBER REPORTED (804950) IS INVALID CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE WAS REPORTED VIA SOCIAL MEDIA: BLADDER INCONTINENCE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2020: UPDATE OF INFORMATION (BATCH IS INVALID). BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WAS CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ('MIGRATED'), LARGE INTESTINE PERFORATION ('POKING INTO MY COLON'), EMBEDDED DEVICE ('MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: OVARY / MALPOSITION OF ESSURE / HAD EMBEDDED ESSURE COIL / MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: EMBEDDED IN RIGHT UTERINE SIDEWALL BY THE OSTIUM, ROBOTIC ASSISTED EXCISION OF RIGHT EMBEDDED'), PELVIC PAIN ('PAIN'), MENORRHAGIA ('ABNORMAL BLEEDING ( MENORRHAGIA)') AND NEPHROLITHIASIS ('OTHER INJURY(IES) OR COMPLICATION PLEASE DESCRIBE: KIDNEY STONES') IN A 36-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. B04960-NOTVALID) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED THYROID NODULAR, CERVICAL PAP SMEAR ABNORMAL, TUMMY TUCK, UTERINE BLEEDING, URETERAL CALCULUS, NEPHROLITHIASIS, VULVOVAGINAL HUMAN PAPILLOMA VIRUS INFECTION, ITCHING, BURNING SENSATION, IRRITATION EYE, BREAST TENDERNESS, GALACTORRHEA, ADHD, ANXIETY, DEPRESSION, PANIC DISORDER, METRORRHAGIA, HEMATURIA, FLANK PAIN, URETEROLITHIASIS, UROLITHIASIS, DIARRHEA, NAUSEA, VOMITING, DEPRESSIVE DISORDER, POST-TRAUMATIC STRESS DISORDER, ATTENTION DEFICIT/HYPERACTIVITY DISORDER AND ASTHMA. CONCOMITANT PRODUCTS INCLUDED ALPRAZOLAM (XANAX) SINCE(B)(6)2016, BUPROPION HYDROCHLORIDE (WELLBUTRIN) SINCE (B)(6)2016, CEFALEXIN (CEPHALEXIN AMEL), ESCITALOPRAM OXALATE (LEXAPRO), FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF), PARACETAMOL (ACETAMINOPHEN) AND PHENAZOPYRIDINE. ON (B)(6)2014, THE PATIENT HAD ESSURE INSERTED. ON (B)(6)2014, THE PATIENT EXPERIENCED INSOMNIA ("LACK OF SLEEP"), HOT FLUSH ("HOT FLASHES") AND MOOD ALTERED ("MOODINESS"), 1 MONTH 25 DAYS AFTER INSERTION OF ESSURE. ON (B)(6)2014, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA"). ON (B)(6)2014, THE PATIENT EXPERIENCED URINARY TRACT INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL), TYPE: URINARY TRACTINFECTION"). ON (B)(6)2014, THE PATIENT EXPERIENCED MENTAL DISORDER ("PHYCHOLOGICAL PROBLEMS OR CONDITION"). ON (B)(6) 2014, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("DYSMENORRHEA"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND FATIGUE ("FATIGUE"). ON (B)(6)2015, THE PATIENT EXPERIENCED NEPHROLITHIASIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON(B)(6)2015, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINE / HEADACHE"). ON (B)(6)2017, THE PATIENT EXPERIENCED EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), LARGE INTESTINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN ("ABDOMINAL PAIN"), ABDOMINAL PAIN LOWER ("LOWER ABDOMIANL PAIN"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), DEPRESSION ("DEPRESSION"), ANXIETY ("ANXIETY") AND URINARY INCONTINENCE ("TROUBLE HOLDING YOUR BLADDER"). THE PATIENT WAS TREATED WITH IBUPROFEN AND SURGERY (ABLATION ON (B)(6)2016 AND LAPAROSCOPIC REMOVAL OF ESSURE CLIPS WITH PARTIAL SALPINGECTOMY, ROBOTIC ASSISTED EXCISION OF RIGHT). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, LARGE INTESTINE PERFORATION, PELVIC PAIN, ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, DYSMENORRHOEA, NEPHROLITHIASIS, DYSPAREUNIA, VAGINAL DISCHARGE, FATIGUE, MENTAL DISORDER, DEPRESSION, ANXIETY AND URINARY INCONTINENCE OUTCOME WAS UNKNOWN AND THE EMBEDDED DEVICE, MENORRHAGIA, VAGINAL HAEMORRHAGE, URINARY TRACT INFECTION, MIGRAINE, INSOMNIA, HOT FLUSH AND MOOD ALTERED HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ANXIETY, DEPRESSION, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, EMBEDDED DEVICE, FATIGUE, HOT FLUSH, INSOMNIA, LARGE INTESTINE PERFORATION, MENORRHAGIA, MENTAL DISORDER, MIGRAINE, MOOD ALTERED, NEPHROLITHIASIS, PELVIC PAIN, URINARY INCONTINENCE, URINARY TRACT INFECTION, VAGINAL DISCHARGE AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED IN ESSURE DATE OF REMOVAL - (B)(6)2016 DISCREPANCY NOTED IN DATE OF BIRTH- (B)(6)1982 DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): COMPUTERISED TOMOGRAM ABDOMEN - ON (B)(6)2016: IMPRESSION: NO ACUTE ABNORMALITY. TINY PUNCTATE NON-OBSTRUCTIVE LEFT NEPHROLITHIASIS. NO OBSTRUCTIVE UROPATHY. STABLE 1.7 CM LEFT RENAL ANGIOMYOLIPOMA. CONSTIPATION STABLE APPEARANCE OF TUBAL LIGATION/STERILIZATION WITH INCOMPLETE VISUALIZATION OF THE LEFT STERILIZATION DEVICE. THIS COULD BE FURTHER EVALUATED WITH HYSTEROSALPINGOGRAPHY. HYSTEROSALPINGOGRAM - ON (B)(6)2014: TOTAL BILATERAL OCCLUSION. MAGNETIC RESONANCE IMAGING ABDOMINAL - ON (B)(6)2017: UTERUS: ACCURATE CONFIGURATION OF THE URETHRA. INTERSTITIAL OR INFUNDIBULAR LOCATION OF THE RIGHT TUBAL OCCLUSION DEVICE EXTENDING INTO THE ISTHMUS OR PROXIMAL TUBE, WITHOUT APPRECIABLE CHANGE IN LOCATION FROM PRIOR CT. SIGNAL DROP OFF ARTRACT (AS WRITTEN) FROM ESSURE WIRE OBSERVES ISTHAMIC SEGMENT. NO REGIONAL COLLECTIONS. NO EXTRA UTERINE OR EXTRA TUBAL MIGRATION.. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS : MENORRHAGIA, KIDNEY STONE, DYSMENORRHEA, ABDOMINAL PAINMIGRAINE, MOOD SWINGS, PELVIC PAIN. LOT NUMBER REPORTED B04960 IS NOT VALID. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE WAS REPORTED VIA SOCIAL MEDIA: BLADDER INCONTINENCE MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 3-FEB-2020: UPDATE OF INFORMATION (BATCH IS NOT VALID) BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WILL BE CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ('MIGRATED'), LARGE INTESTINE PERFORATION ('POKING INTO MY COLON'), EMBEDDED DEVICE ('MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: OVARY / MALPOSITION OF ESSURE / HAD EMBEDDED ESSURE COIL / MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: EMBEDDED IN RIGHT UTERINE SIDEWALL BY THE OSTIUM, ROBOTIC ASSISTED EXCISION OF RIGHT EMBEDDED'), PELVIC PAIN ('PAIN'), MENORRHAGIA ('ABNORMAL BLEEDING ( MENORRHAGIA)') AND NEPHROLITHIASIS ('OTHER INJURY(IES) OR COMPLICATION PLEASE DESCRIBE: KIDNEY STONES') IN A 36-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. B04960-NOT VALID) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED THYROID NODULAR, CERVICAL PAP SMEAR ABNORMAL, TUMMY TUCK, UTERINE BLEEDING, URETERAL CALCULUS, NEPHROLITHIASIS, VULVOVAGINAL HUMAN PAPILLOMA VIRUS INFECTION, ITCHING, BURNING SENSATION, IRRITATION EYE, BREAST TENDERNESS, GALACTORRHEA, ADHD, ANXIETY, DEPRESSION, PANIC DISORDER, METRORRHAGIA, HEMATURIA, FLANK PAIN, URETEROLITHIASIS, UROLITHIASIS, DIARRHEA, NAUSEA, VOMITING, DEPRESSIVE DISORDER, POST-TRAUMATIC STRESS DISORDER, ATTENTION DEFICIT/HYPERACTIVITY DISORDER AND ASTHMA. CONCOMITANT PRODUCTS INCLUDED ALPRAZOLAM (XANAX) SINCE (B)(6)2016, BUPROPION HYDROCHLORIDE (WELLBUTRIN) SINCE (B)(6)2016, CEFALEXIN (CEPHALEXIN AMEL), ESCITALOPRAM OXALATE (LEXAPRO), FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF), PARACETAMOL (ACETAMINOPHEN) AND PHENAZOPYRIDINE. ON (B)(6)2014, THE PATIENT HAD ESSURE INSERTED. ON (B)(6)2014, THE PATIENT EXPERIENCED INSOMNIA ("LACK OF SLEEP"), HOT FLUSH ("HOT FLASHES") AND MOOD ALTERED ("MOODINESS"), 1 MONTH 25 DAYS AFTER INSERTION OF ESSURE. ON (B)(6)-2014, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA"). ON (B)(6)2014, THE PATIENT EXPERIENCED URINARY TRACT INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL), TYPE: URINARY TRACT INFECTION"). ON (B)(6)2014, THE PATIENT EXPERIENCED MENTAL DISORDER ("PHYCOLOGICAL PROBLEMS OR CONDITION"). ON (B)(6)2014, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("DYSMENORRHEA"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND FATIGUE ("FATIGUE"). ON (B)(6)2015, THE PATIENT EXPERIENCED NEPHROLITHIASIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON (B)(6)2015, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINE / HEADACHE"). ON (B)(6)2017, THE PATIENT EXPERIENCED EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), LARGE INTESTINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN ("ABDOMINAL PAIN"), ABDOMINAL PAIN LOWER ("LOWER ABDOMINAL PAIN"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), DEPRESSION ("DEPRESSION"), ANXIETY ("ANXIETY") AND URINARY INCONTINENCE ("TROUBLE HOLDING YOUR BLADDER"). THE PATIENT WAS TREATED WITH IBUPROFEN AND SURGERY (ABLATION ON (B)(6)2016 AND LAPAROSCOPIC REMOVAL OF ESSURE CLIPS WITH PARTIAL SALPINGECTOMY, ROBOTIC ASSISTED EXCISION OF RIGHT). ESSURE WAS REMOVED ON (B)(6)2018. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, LARGE INTESTINE PERFORATION, PELVIC PAIN, ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, DYSMENORRHOEA, NEPHROLITHIASIS, DYSPAREUNIA, VAGINAL DISCHARGE, FATIGUE, MENTAL DISORDER, DEPRESSION, ANXIETY AND URINARY INCONTINENCE OUTCOME WAS UNKNOWN AND THE EMBEDDED DEVICE, MENORRHAGIA, VAGINAL HAEMORRHAGE, URINARY TRACT INFECTION, MIGRAINE, INSOMNIA, HOT FLUSH AND MOOD ALTERED HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ANXIETY, DEPRESSION, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, EMBEDDED DEVICE, FATIGUE, HOT FLUSH, INSOMNIA, LARGE INTESTINE PERFORATION, MENORRHAGIA, MENTAL DISORDER, MIGRAINE, MOOD ALTERED, NEPHROLITHIASIS, PELVIC PAIN, URINARY INCONTINENCE, URINARY TRACT INFECTION, VAGINAL DISCHARGE AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED IN ESSURE DATE OF REMOVAL - (B)(6)2016. DISCREPANCY NOTED IN DATE OF BIRTH- (B)(6)1982. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): COMPUTERISED TOMOGRAM ABDOMEN - ON (B)(6)2016: IMPRESSION: NO ACUTE ABNORMALITY. TINY PUNCTATE NON-OBSTRUCTIVE LEFT NEPHROLITHIASIS. NO OBSTRUCTIVE UROPATHY. STABLE 1.7 CM LEFT RENAL ANGIOMYOLIPOMA. CONSTIPATION STABLE APPEARANCE OF TUBAL LIGATION/STERILIZATION WITH INCOMPLETE VISUALIZATION OF THE LEFT STERILIZATION DEVICE. THIS COULD BE FURTHER EVALUATED WITH HYSTEROSALPINGOGRAPHY. HYSTEROSALPINGOGRAM - ON (B)(6)2014: TOTAL BILATERAL OCCLUSION. MAGNETIC RESONANCE IMAGING ABDOMINAL - ON (B)(6)2017: UTERUS: ACCURATE CONFIGURATION OF THE URETHRA. INTERSTITIAL OR INFUNDIBULAR LOCATION OF THE RIGHT TUBAL OCCLUSION DEVICE EXTENDING INTO THE ISTHMUS OR PROXIMAL TUBE, WITHOUT APPRECIABLE CHANGE IN LOCATION FROM PRIOR CT. SIGNAL DROP OFF ATTRACT (AS WRITTEN) FROM ESSURE WIRE OBSERVES ISTHMIC SEGMENT. NO REGIONAL COLLECTIONS. NO EXTRA UTERINE OR EXTRA TUBAL MIGRATION.. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS : MENORRHAGIA, KIDNEY STONE, DYSMENORRHEA, ABDOMINAL PAIN MIGRAINE, MOOD SWINGS, PELVIC PAIN. LOT NUMBER REPORTED B04960 IS NOT VALID. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE WAS REPORTED VIA SOCIAL MEDIA: BLADDER INCONTINENCE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 14-JAN-2020: SOCIAL MEDIA RECEIVED- NEW EVENT TROUBLE HOLDING YOUR BLADDER WAS ADDED. REPORTER INFORMATION WAS ADDED. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WILL BE CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ('MIGRATED'), LARGE INTESTINE PERFORATION ('POKING INTO MY COLON'), EMBEDDED DEVICE ('MIGRATION OF ESSURE: OVARY/ MALPOSITION OF ESSURE/ HAD EMBEDDED ESSURE COIL/ MIGRATION OF ESSURE: EMBEDDED IN RIGHT UTERINE SIDEWALL BY THE OSTIUM, ROBOTIC ASSISTED EXCISION OF RIGHT EMBEDDED'), PELVIC PAIN, MENORRHAGIA ('ABNORMAL BLEEDING ( MENORRHAGIA)') AND NEPHROLITHIASIS ('OTHER INJURY(IES) OR COMPLICATION PLEASE DESCRIBE: KIDNEY STONES') IN A 36-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. B04960-INV,804950-INV) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED THYROID NODULAR, CERVICAL PAP SMEAR ABNORMAL, TUMMY TUCK, UTERINE BLEEDING, URETERAL CALCULUS, NEPHROLITHIASIS, VULVOVAGINAL HUMAN PAPILLOMA VIRUS INFECTION, ITCHING, BURNING SENSATION, IRRITATION EYE, BREAST TENDERNESS, GALACTORRHEA, ADHD, ANXIETY, DEPRESSION, PANIC DISORDER, METRORRHAGIA, HEMATURIA, FLANK PAIN, URETEROLITHIASIS, UROLITHIASIS, DIARRHEA, NAUSEA, VOMITING, DEPRESSIVE DISORDER, POST-TRAUMATIC STRESS DISORDER, ATTENTION DEFICIT/HYPERACTIVITY DISORDER AND ASTHMA. CONCOMITANT PRODUCTS INCLUDED ALPRAZOLAM (XANAX) SINCE (B)(6) 2016, BUPROPION HYDROCHLORIDE (WELLBUTRIN) SINCE (B)(6) 2016, CEFALEXIN (CEPHALEXIN AMEL), ESCITALOPRAM OXALATE (LEXAPRO), FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF), PARACETAMOL (ACETAMINOPHEN) AND PHENAZOPYRIDINE. ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2014, THE PATIENT EXPERIENCED INSOMNIA ("LACK OF SLEEP"), HOT FLUSH ("HOT FLASHES") AND MOOD ALTERED ("MOODINESS"), 1 MONTH 25 DAYS AFTER INSERTION OF ESSURE. ON (B)(6) 2014, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA"). ON (B)(6) 2014, THE PATIENT EXPERIENCED URINARY TRACT INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL), TYPE: URINARY TRACT INFECTION"). ON (B)(6) 2014, THE PATIENT EXPERIENCED MENTAL DISORDER ("PSYCHOLOGICAL PROBLEMS OR CONDITION"). ON (B)(6) 2014, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("DYSMENORRHEA"), VAGINAL HEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND FATIGUE ("FATIGUE"). ON (B)(6) 2015, THE PATIENT EXPERIENCED NEPHROLITHIASIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON (B)(6) 2015, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINE / HEADACHE"). ON (B)(6) 2018, THE PATIENT EXPERIENCED EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), LARGE INTESTINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN ("ABDOMINAL PAIN"), ABDOMINAL PAIN LOWER ("LOWER ABDOMINAL PAIN"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), DEPRESSION ("DEPRESSION"), ANXIETY ("ANXIETY"), URINARY INCONTINENCE ("TROUBLE HOLDING YOUR BLADDER"), ALOPECIA ("HAIR LOSS") AND THYROID DISORDER ("THYROID PROBLEM"). THE PATIENT WAS TREATED WITH IBUPROFEN AND SURGERY (ABLATION ON (B)(6) 2016 AND LAPAROSCOPIC REMOVAL OF ESSURE CLIPS WITH PARTIAL SALPINGECTOMY, ROBOTIC ASSISTED EXCISION OF RIGHT). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, LARGE INTESTINE PERFORATION, PELVIC PAIN, ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, DYSMENORRHOEA, NEPHROLITHIASIS, DYSPAREUNIA, VAGINAL DISCHARGE, FATIGUE, MENTAL DISORDER, DEPRESSION, ANXIETY, URINARY INCONTINENCE, ALOPECIA AND THYROID DISORDER OUTCOME WAS UNKNOWN AND THE EMBEDDED DEVICE, MENORRHAGIA, VAGINAL HEMORRHAGE, URINARY TRACT INFECTION, MIGRAINE, INSOMNIA, HOT FLUSH AND MOOD ALTERED HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ALOPECIA, ANXIETY, DEPRESSION, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, EMBEDDED DEVICE, FATIGUE, HOT FLUSH, INSOMNIA, LARGE INTESTINE PERFORATION, MENORRHAGIA, MENTAL DISORDER, MIGRAINE, MOOD ALTERED, NEPHROLITHIASIS, PELVIC PAIN, THYROID DISORDER, URINARY INCONTINENCE, URINARY TRACT INFECTION, VAGINAL DISCHARGE AND VAGINAL HEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED IN ESSURE DATE OF REMOVAL - (B)(6) 2016. DISCREPANCY NOTED IN DATE OF BIRTH- (B)(6) 1982. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): COMPUTERISED TOMOGRAM ABDOMEN - ON (B)(6) 2016: IMPRESSION: NO ACUTE ABNORMALITY. TINY PUNCTATE NON-OBSTRUCTIVE LEFT NEPHROLITHIASIS. NO OBSTRUCTIVE UROPATHY. STABLE 1.7 CM LEFT RENAL ANGIOMYOLIPOMA. CONSTIPATION STABLE APPEARANCE OF TUBAL LIGATION/STERILIZATION WITH INCOMPLETE VISUALIZATION OF THE LEFT STERILIZATION DEVICE. THIS COULD BE FURTHER EVALUATED WITH HYSTEROSALPINGOGRAPHY. HYSTEROSALPINGOGRAM - ON (B)(6) 2014: TOTAL BILATERAL OCCLUSION. MAGNETIC RESONANCE IMAGING ABDOMINAL - ON (B)(6) 2017: UTERUS: ACCURATE CONFIGURATION OF THE URETHRA. INTERSTITIAL OR INFUNDIBULAR LOCATION OF THE RIGHT TUBAL OCCLUSION DEVICE EXTENDING INTO THE ISTHMUS OR PROXIMAL TUBE, WITHOUT APPRECIABLE CHANGE IN LOCATION FROM PRIOR CT. SIGNAL DROP OFF ABSTRACT (AS WRITTEN) FROM ESSURE WIRE OBSERVES ISTHAMIC SEGMENT. NO REGIONAL COLLECTIONS. NO EXTRA UTERINE OR EXTRA TUBAL MIGRATION. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS : MENORRHAGIA, KIDNEY STONE, DYSMENORRHEA, ABDOMINAL PAIN MIGRAINE, MOOD SWINGS, PELVIC PAIN. LOT NUMBER REPORTED B04960 IS NOT VALID. THE LOT NUMBER REPORTED (804950) IS INVALID. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE WAS REPORTED VIA SOCIAL MEDIA: BLADDER INCONTINENCE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 23-MAR-2020: SOCIAL MEDIA RECEIVED. EVENT HAIR LOSS, THYROID PROBLEM ADDED. REPORTER ADDED. ON 23-MAR-2020: PROCESSED WITH FU 13. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WILL BE CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PAIN'), EMBEDDED DEVICE ('MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: OVARY / MALPOSITION OF ESSURE / HAD EMBEDDED ESSURE COIL / MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: EMBEDDED IN RIGHT UTERINE SIDEWALL BY THE OSTIUM'), MENORRHAGIA ('ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA),') AND NEPHROLITHIASIS ('OTHER INJURY(IES) OR COMPLICATION PLEASE DESCRIBE: KIDNEY STONES') IN A 36-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. B04960-NOT VALID) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED THYROID NODULAR, CERVICAL PAP SMEAR ABNORMAL, TUMMY TUCK, UTERINE BLEEDING, URETERAL CALCULUS, NEPHROLITHIASIS, VULVOVAGINAL HUMAN PAPILLOMA VIRUS INFECTION, ITCHING, BURNING SENSATION, IRRITATION EYE, BREAST TENDERNESS, GALACTORRHEA, ADHD, ANXIETY, DEPRESSION, PANIC DISORDER, METRORRHAGIA, HEMATURIA, FLANK PAIN, URETEROLITHIASIS, UROLITHIASIS, DIARRHEA, NAUSEA, VOMITING, DEPRESSIVE DISORDER, POST-TRAUMATIC STRESS DISORDER, ATTENTION DEFICIT/HYPERACTIVITY DISORDER AND ASTHMA. CONCOMITANT PRODUCTS INCLUDED ALPRAZOLAM (XANAX) SINCE (B)(6) 2016, BUPROPION HYDROCHLORIDE (WELLBUTRIN) SINCE (B)(6) 2016, CEFALEXIN (CEPHALEXIN AMEL), ESCITALOPRAM OXALATE (LEXAPRO), FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF), PARACETAMOL (ACETAMINOPHEN) AND PHENAZOPYRIDINE. ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2014, THE PATIENT EXPERIENCED INSOMNIA ("LACK OF SLEEP"), HOT FLUSH ("HOT FLASHES") AND MOOD ALTERED ("MOODINESS"), 1 MONTH 25 DAYS AFTER INSERTION OF ESSURE. ON (B)(6) 2014, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA"). ON (B)(6) 2014, THE PATIENT EXPERIENCED URINARY TRACT INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL), TYPE: URINARY STRATIFICATION"). ON (B)(6) 2014, THE PATIENT EXPERIENCED MENTAL DISORDER ("PHYCOLOGICAL PROBLEMS OR CONDITION"). ON (B)(6) 2014, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("DYSMENORRHEA"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA),") AND FATIGUE ("FATIGUE"). ON (B)(6) 2015, THE PATIENT EXPERIENCED NEPHROLITHIASIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON (B)(6) 2015, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINE / HEADACHE"). ON (B)(6) 2017, THE PATIENT EXPERIENCED EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN ("ABDOMINAL PAIN"), ABDOMINAL PAIN LOWER ("LOWER ABDOMINAL PAIN"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), DEPRESSION ("DEPRESSION") AND ANXIETY ("ANXIETY"). THE PATIENT WAS TREATED WITH IBUPROFEN AND SURGERY (ABLATION ON (B)(6) 2016 AND LAPAROSCOPIC REMOVAL OF ESSURE CLIPS WITH PARTIAL SALPINGECTOMY, ROBOTIC ASSISTED EXCISION OF RIGHT). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, DYSMENORRHOEA, NEPHROLITHIASIS, DYSPAREUNIA, VAGINAL DISCHARGE, FATIGUE, MENTAL DISORDER, DEPRESSION AND ANXIETY OUTCOME WAS UNKNOWN AND THE EMBEDDED DEVICE, MENORRHAGIA, VAGINAL HAEMORRHAGE, URINARY TRACT INFECTION, MIGRAINE, INSOMNIA, HOT FLUSH AND MOOD ALTERED HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ANXIETY, DEPRESSION, DYSMENORRHOEA, DYSPAREUNIA, EMBEDDED DEVICE, FATIGUE, HOT FLUSH, INSOMNIA, MENORRHAGIA, MENTAL DISORDER, MIGRAINE, MOOD ALTERED, NEPHROLITHIASIS, PELVIC PAIN, URINARY TRACT INFECTION, VAGINAL DISCHARGE AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED IN ESSURE DATE OF REMOVAL - (B)(6) 2016 DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2014: TOTAL BILATERAL OCCLUSION. COMPUTERISED TOMOGRAM ABDOMEN - ON (B)(6) 2016: IMPRESSION: NO ACUTE ABNORMALITY. TINY PUNCTATE NON-OBSTRUCTIVE LEFT NEPHROLITHIASIS. NO OBSTRUCTIVE UROPATHY. STABLE 1.7 CM LEFT RENAL ANGIOMYOLIPOMA. CONSTIPATION STABLE APPEARANCE OF TUBAL LIGATION/STERILIZATION WITH INCOMPLETE VISUALIZATION OF THE LEFT STERILIZATION DEVICE. THIS COULD BE FURTHER EVALUATED WITH HYSTEROSALPINGOGRAPHY. NUCLEAR MAGNETIC RESONANCE IMAGING ABDOMINAL - ON (B)(6) 2017: UTERUS: ACCURATE CONFIGURATION OF THE URETHRA. INTERSTITIAL OR INFUNDIBULAR LOCATION OF THE RIGHT TUBAL OCCLUSION DEVICE EXTENDING INTO THE ISTHMUS OR PROXIMAL TUBE, WITHOUT APPRECIABLE CHANGE IN LOCATION FROM PRIOR CT. SIGNAL DROP OFF ATTRACT (AS WRITTEN) FROM ESSURE WIRE OBSERVES ISTHAMIC SEGMENT. NO REGIONAL COLLECTIONS. NO EXTRA UTERINE OR EXTRA TUBAL MIGRATION.. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS : MENORRHAGIA, KIDNEY STONE, DYSMENORRHEA, ABDOMINAL PAINMIGRAINE, MOOD SWINGS, PELVIC PAIN. LOT NUMBER REPORTED B04960 IS NOT VALID. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2019: PFS RECEIVED : REPORTER AND CONCOMITANT DRUG ADDED. EVENTS - DEPRESSION AND ANXIETY WERE ADDED. NO VALID LOT NUMBER OR DEVICE SAMPLE WAS RECEIVED IN THIS CASE. AT THIS TIME, WE HAVE NO INFORMATION SUGGESTING THAT THE DEVICE FAILED TO MEET ITS SPECIFICATIONS. WE WILL CONDUCT A REVIEW OF OUR COMPLAINT RECORDS AND OTHER NON-CONFORMANCE'S DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN"), EMBEDDED DEVICE ("MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: OVARY / MALPOSITION OF ESSURE / HAD EMBEDDED ESSURE COIL"), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA),") AND NEPHROLITHIASIS ("OTHER INJURY(IES) OR COMPLICATION PLEASE DESCRIBE: KIDNEY STONES") IN A 36-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. B04960-INVALID) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED THYROID NODULAR, CERVICAL PAP SMEAR ABNORMAL, TUMMY TUCK, UTERINE BLEEDING, URETERAL CALCULUS, NEPHROLITHIASIS, VULVOVAGINAL HUMAN PAPILLOMA VIRUS INFECTION, ITCHING, BURNING SENSATION, IRRITATION EYE, BREAST TENDERNESS, GALACTORRHEA, ADHD, ANXIETY, DEPRESSION, PANIC DISORDER, METRORRHAGIA, HEMATURIA, FLANK PAIN, URETEROLITHIASIS, UROLITHIASIS, DIARRHEA, NAUSEA, VOMITING, DEPRESSIVE DISORDER, POST-TRAUMATIC STRESS DISORDER, ATTENTION DEFICIT/HYPERACTIVITY DISORDER AND ASTHMA. CONCOMITANT PRODUCTS INCLUDED CEFALEXIN (CEPHALEXIN AMEL), ESCITALOPRAM OXALATE (LEXAPRO), FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF), PARACETAMOL (ACETAMINOPHEN) AND PHENAZOPYRIDINE. ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2014, THE PATIENT EXPERIENCED INSOMNIA ("LACK OF SLEEP"), HOT FLUSH ("HOT FLASHES") AND MOOD ALTERED ("MOODINESS"), 1 MONTH 25 DAYS AFTER INSERTION OF ESSURE. ON (B)(6) 2014, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA"). ON (B)(6) 2014, THE PATIENT EXPERIENCED MENTAL DISORDER ("PHYCHOLOGICAL PROBLEMS OR CONDITION"). ON (B)(6) 2014, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA),"), DYSMENORRHOEA ("DYSMENORRHEA") AND FATIGUE ("FATIGUE"). ON (B)(6) 2015, THE PATIENT EXPERIENCED NEPHROLITHIASIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON (B)(6) 2015, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES") AND HEADACHE ("HEADACHES"). ON (B)(6) 2017, THE PATIENT EXPERIENCED EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED URINARY TRACT INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL), TYPE: URINARY TRACTINFECTION"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), ABDOMINAL PAIN LOWER ("LOWER ABDOMINAL PAIN") AND ABDOMINAL PAIN ("ABDOMINAL PAIN"). THE PATIENT WAS TREATED WITH IBUPROFEN AND SURGERY (ABLATION AND LAPAROSCOPIC REMOVAL OF ESSURE CLIPS WITH PARTIAL SALPINGECTOMY, ROBOTIC ASSISTED EXCISION OF RIGHT). AT THE TIME OF THE REPORT, THE PELVIC PAIN, NEPHROLITHIASIS, HEADACHE, DYSMENORRHOEA, DYSPAREUNIA, VAGINAL DISCHARGE, FATIGUE, MENTAL DISORDER, ABDOMINAL PAIN LOWER AND ABDOMINAL PAIN OUTCOME WAS UNKNOWN AND THE EMBEDDED DEVICE, MENORRHAGIA, VAGINAL HAEMORRHAGE, URINARY TRACT INFECTION, MIGRAINE, INSOMNIA, HOT FLUSH AND MOOD ALTERED HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, DYSMENORRHOEA, DYSPAREUNIA, EMBEDDED DEVICE, FATIGUE, HEADACHE, HOT FLUSH, INSOMNIA, MENORRHAGIA, MENTAL DISORDER, MIGRAINE, MOOD ALTERED, NEPHROLITHIASIS, PELVIC PAIN, URINARY TRACT INFECTION, VAGINAL DISCHARGE AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED IN ESSURE DATE OF REMOVAL - (B)(6) 2016. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): COMPUTERISED TOMOGRAM ABDOMEN - ON (B)(6) 2016: IMPRESSION: NO ACUTE ABNORMALITY. TINY PUNCTATE NON-OBSTRUCTIVE LEFT NEPHROLITHIASIS. NO OBSTRUCTIVE UROPATHY. STABLE 1.7 CM LEFT RENAL ANGIOMYOLIPOMA. CONSTIPATION STABLE APPEARANCE OF TUBAL LIGATION/STERILIZATION WITH INCOMPLETE VISUALIZATION OF THE LEFT STERILIZATION DEVICE. THIS COULD BE FURTHER EVALUATED WITH HYSTEROSALPINGOGRAPHY. HYSTEROSALPINGOGRAM - ON (B)(6) 2014: TOTAL BILATERAL OCCLUSION. NUCLEAR MAGNETIC RESONANCE IMAGING ABDOMINAL - ON (B)(6) 2017: FINDINGS: UTERUS: ACCURATE CONFIGURATION OF THE URETHRA. INTERSTITIAL OR INFUNDIBULAR LOCATION OF THE RIGHT TUBAL OCCLUSION DEVICE EXTENDING INTO THE ISTHMUS OR PROXIMAL TUBE, WITHOUT APPRECIABLE CHANGE IN LOCATION FROM PRIOR CT. SIGNAL DROP OFF ATTRACT (AS WRITTEN) FROM ESSURE WIRE OBSERVES ISTHAMIC SEGMENT. NO REGIONAL COLLECTIONS. NO EXTRA UTERINE OR EXTRA TUBAL MIGRATION. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS : MENORRHAGIA, KIDNEY STONE, DYSMENORRHEA, ABDOMINAL PAIN, MIGRAINE, MOOD SWINGS, PELVIC PAIN. LOT NUMBER REPORTED B04960 IS INVALID. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2019: UPDATE OF INFORMATION (BATCH IS INVALID) (PRODUCT TECHNICAL COMPLAINT). INCIDENT: NO LOT NUMBER OR DEVICE SAMPLE WAS RECEIVED IN THIS CASE. AT THIS TIME, WE HAVE NO INFORMATION SUGGESTING THAT THE DEVICE FAILED TO MEET ITS SPECIFICATIONS. WE WILL CONDUCT A REVIEW OF OUR COMPLAINT RECORDS AND OTHER NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ('MIGRATED'), LARGE INTESTINE PERFORATION ('POKING INTO MY COLON'), EMBEDDED DEVICE ('MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: OVARY / MALPOSITION OF ESSURE / HAD EMBEDDED ESSURE COIL / MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: EMBEDDED IN RIGHT UTERINE SIDEWALL BY THE OSTIUM, ROBOTIC ASSISTED EXCISION OF RIGHT EMBEDDED'), PELVIC PAIN ('PAIN'), MENORRHAGIA ('ABNORMAL BLEEDING ( MENORRHAGIA)') AND NEPHROLITHIASIS ('OTHER INJURY(IES) OR COMPLICATION PLEASE DESCRIBE: KIDNEY STONES') IN A 36-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. B04960-NOT VALID) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED THYROID NODULAR, CERVICAL PAP SMEAR ABNORMAL, TUMMY TUCK, UTERINE BLEEDING, URETERAL CALCULUS, NEPHROLITHIASIS, VULVOVAGINAL HUMAN PAPILLOMA VIRUS INFECTION, ITCHING, BURNING SENSATION, IRRITATION EYE, BREAST TENDERNESS, GALACTORRHEA, ADHD, ANXIETY, DEPRESSION, PANIC DISORDER, METRORRHAGIA, HEMATURIA, FLANK PAIN, URETEROLITHIASIS, UROLITHIASIS, DIARRHEA, NAUSEA, VOMITING, DEPRESSIVE DISORDER, POST-TRAUMATIC STRESS DISORDER, ATTENTION DEFICIT/HYPERACTIVITY DISORDER AND ASTHMA. CONCOMITANT PRODUCTS INCLUDED ALPRAZOLAM (XANAX) SINCE (B)(6) 2016, BUPROPION HYDROCHLORIDE (WELLBUTRIN) SINCE (B)(6) 2016, CEFALEXIN (CEPHALEXIN AMEL), ESCITALOPRAM OXALATE (LEXAPRO), FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF), PARACETAMOL (ACETAMINOPHEN) AND PHENAZOPYRIDINE. ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2014, THE PATIENT EXPERIENCED INSOMNIA ("LACK OF SLEEP"), HOT FLUSH ("HOT FLASHES") AND MOOD ALTERED ("MOODINESS"), 1 MONTH 25 DAYS AFTER INSERTION OF ESSURE. ON (B)(6) 2014, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA"). ON (B)(6) 2014, THE PATIENT EXPERIENCED URINARY TRACT INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL), TYPE: URINARY TRACTINFECTION"). ON (B)(6) 2014, THE PATIENT EXPERIENCED MENTAL DISORDER ("PHYCHOLOGICAL PROBLEMS OR CONDITION"). ON (B)(6) 2014, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("DYSMENORRHEA"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND FATIGUE ("FATIGUE"). ON (B)(6) 2015, THE PATIENT EXPERIENCED NEPHROLITHIASIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON (B)(6) 2015, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINE / HEADACHE"). ON (B)(6) 2017, THE PATIENT EXPERIENCED EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), LARGE INTESTINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN ("ABDOMINAL PAIN"), ABDOMINAL PAIN LOWER ("LOWER ABDOMIANL PAIN"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), DEPRESSION ("DEPRESSION") AND ANXIETY ("ANXIETY"). THE PATIENT WAS TREATED WITH IBUPROFEN AND SURGERY (ABLATION ON (B)(6) 2016 AND LAPAROSCOPIC REMOVAL OF ESSURE CLIPS WITH PARTIAL SALPINGECTOMY, ROBOTIC ASSISTED EXCISION OF RIGHT). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, LARGE INTESTINE PERFORATION, PELVIC PAIN, ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, DYSMENORRHOEA, NEPHROLITHIASIS, DYSPAREUNIA, VAGINAL DISCHARGE, FATIGUE, MENTAL DISORDER, DEPRESSION AND ANXIETY OUTCOME WAS UNKNOWN AND THE EMBEDDED DEVICE, MENORRHAGIA, VAGINAL HAEMORRHAGE, URINARY TRACT INFECTION, MIGRAINE, INSOMNIA, HOT FLUSH AND MOOD ALTERED HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ANXIETY, DEPRESSION, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, EMBEDDED DEVICE, FATIGUE, HOT FLUSH, INSOMNIA, LARGE INTESTINE PERFORATION, MENORRHAGIA, MENTAL DISORDER, MIGRAINE, MOOD ALTERED, NEPHROLITHIASIS, PELVIC PAIN, URINARY TRACT INFECTION, VAGINAL DISCHARGE AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED IN ESSURE DATE OF REMOVAL - (B)(6) 2016. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): COMPUTERISED TOMOGRAM ABDOMEN - ON (B)(6) 2016: IMPRESSION: NO ACUTE ABNORMALITY. TINY PUNCTATE NON-OBSTRUCTIVE LEFT NEPHROLITHIASIS. NO OBSTRUCTIVE UROPATHY. STABLE 1.7 CM LEFT RENAL ANGIOMYOLIPOMA. CONSTIPATION STABLE APPEARANCE OF TUBAL LIGATION/STERILIZATION WITH INCOMPLETE VISUALIZATION OF THE LEFT STERILIZATION DEVICE. THIS COULD BE FURTHER EVALUATED WITH HYSTEROSALPINGOGRAPHY. HYSTEROSALPINGOGRAM - ON (B)(6) 2014: TOTAL BILATERAL OCCLUSION. MAGNETIC RESONANCE IMAGING ABDOMINAL - ON (B)(6) 2017: UTERUS: ACCURATE CONFIGURATION OF THE URETHRA. INTERSTITIAL OR INFUNDIBULAR LOCATION OF THE RIGHT TUBAL OCCLUSION DEVICE EXTENDING INTO THE ISTHMUS OR PROXIMAL TUBE, WITHOUT APPRECIABLE CHANGE IN LOCATION FROM PRIOR CT. SIGNAL DROP OFF ARTRACT (AS WRITTEN) FROM ESSURE WIRE OBSERVES ISTHAMIC SEGMENT. NO REGIONAL COLLECTIONS. NO EXTRA UTERINE OR EXTRA TUBAL MIGRATION. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS : MENORRHAGIA, KIDNEY STONE, DYSMENORRHEA, ABDOMINAL PAINMIGRAINE, MOOD SWINGS, PELVIC PAIN. LOT NUMBER REPORTED B04960 IS NOT VALID. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2019: SOCIAL MEDIA RECEIVED: EVENTS: MIGRATED, POKING INTO MY COLON WERE ADDED. REPORTER ADDED. INCIDENT: NO VALID LOT NUMBER OR DEVICE SAMPLE WAS RECEIVED IN THIS CASE. AT THIS TIME, WE HAVE NO INFORMATION SUGGESTING THAT THE DEVICE FAILED TO MEET ITS SPECIFICATIONS. WE WILL CONDUCT A REVIEW OF OUR COMPLAINT RECORDS AND OTHER NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN"), EMBEDDED DEVICE ("MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: OVARY / MALPOSITION OF ESSURE / HAD EMBEDDED ESSURE COIL"), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA),") AND NEPHROLITHIASIS ("OTHER INJURY(IES) OR COMPLICATION PLEASE DESCRIBE: KIDNEY STONES") IN A (B)(6) YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. B04960) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED THYROID NODULAR, CERVICAL PAP SMEAR ABNORMAL, TUMMY TUCK, UTERINE BLEEDING, URETERAL CALCULUS, NEPHROLITHIASIS, VULVOVAGINAL (B)(6) INFECTION, ITCHING, BURNING SENSATION, IRRITATION EYE, BREAST TENDERNESS, GALACTORRHEA, ADHD, ANXIETY, DEPRESSION, PANIC DISORDER, METRORRHAGIA, HEMATURIA, FLANK PAIN, URETEROLITHIASIS, UROLITHIASIS, DIARRHEA, NAUSEA, VOMITING, DEPRESSIVE DISORDER, POST-TRAUMATIC STRESS DISORDER, ATTENTION DEFICIT/HYPERACTIVITY DISORDER AND ASTHMA. CONCOMITANT PRODUCTS INCLUDED CEFALEXIN (CEPHALEXIN AMEL), ESCITALOPRAM OXALATE (LEXAPRO), FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF), PARACETAMOL (ACETAMINOPHEN) AND PHENAZOPYRIDINE. ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2014, THE PATIENT EXPERIENCED INSOMNIA ("LACK OF SLEEP"), HOT FLUSH ("HOT FLASHES") AND MOOD ALTERED ("MOODINESS"), 1 MONTH 25 DAYS AFTER INSERTION OF ESSURE. ON (B)(6) 2014, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA"). ON (B)(6) 2014, THE PATIENT EXPERIENCED MENTAL DISORDER ("PSYCHOLOGICAL PROBLEMS OR CONDITION"). ON (B)(6) 2014, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA),"), DYSMENORRHOEA ("DYSMENORRHEA") AND FATIGUE ("FATIGUE"). ON (B)(6) 2015, THE PATIENT EXPERIENCED NEPHROLITHIASIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON (B)(6) 2015, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES") AND HEADACHE ("HEADACHES"). ON (B)(6) 2017, THE PATIENT EXPERIENCED EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED URINARY TRACT INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL), TYPE: URINARY TRACT INFECTION"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), ABDOMINAL PAIN LOWER ("LOWER ABDOMINAL PAIN") AND ABDOMINAL PAIN ("ABDOMINAL PAIN"). THE PATIENT WAS TREATED WITH IBUPROFEN AND SURGERY (ABLATION AND LAPAROSCOPIC REMOVAL OF ESSURE CLIPS WITH PARTIAL SALPINGECTOMY, ROBOTIC ASSISTED EXCISION OF RIGHT). AT THE TIME OF THE REPORT, THE PELVIC PAIN, NEPHROLITHIASIS, HEADACHE, DYSMENORRHOEA, DYSPAREUNIA, VAGINAL DISCHARGE, FATIGUE, MENTAL DISORDER, ABDOMINAL PAIN LOWER AND ABDOMINAL PAIN OUTCOME WAS UNKNOWN AND THE EMBEDDED DEVICE, MENORRHAGIA, VAGINAL HAEMORRHAGE, URINARY TRACT INFECTION, MIGRAINE, INSOMNIA, HOT FLUSH AND MOOD ALTERED HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, DYSMENORRHOEA, DYSPAREUNIA, EMBEDDED DEVICE, FATIGUE, HEADACHE, HOT FLUSH, INSOMNIA, MENORRHAGIA, MENTAL DISORDER, MIGRAINE, MOOD ALTERED, NEPHROLITHIASIS, PELVIC PAIN, URINARY TRACT INFECTION, VAGINAL DISCHARGE AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED IN ESSURE DATE OF REMOVAL - (B)(6) 2016. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): COMPUTERISED TOMOGRAM ABDOMEN - ON (B)(6) 2016: IMPRESSION: NO ACUTE ABNORMALITY. TINY PUNCTATE NON-OBSTRUCTIVE LEFT NEPHROLITHIASIS. NO OBSTRUCTIVE UROPATHY. STABLE 1.7 CM LEFT RENAL ANGIOMYOLIPOMA. CONSTIPATION STABLE APPEARANCE OF TUBAL LIGATION/STERILIZATION WITH INCOMPLETE VISUALIZATION OF THE LEFT STERILIZATION DEVICE. THIS COULD BE FURTHER EVALUATED WITH HYSTEROSALPINGOGRAPHY. HYSTEROSALPINGOGRAM - ON (B)(6) 2014: TOTAL BILATERAL OCCLUSION. NUCLEAR MAGNETIC RESONANCE IMAGING ABDOMINAL - ON (B)(6) 2017: FINDINGS: UTERUS: ACCURATE CONFIGURATION OF THE URETHRA. INTERSTITIAL OR INFUNDIBULAR LOCATION OF THE RIGHT TUBAL OCCLUSION DEVICE EXTENDING INTO THE ISTHMUS OR PROXIMAL TUBE, WITHOUT APPRECIABLE CHANGE IN LOCATION FROM PRIOR CT. SIGNAL DROP OFF ATTRACT (AS WRITTEN) FROM ESSURE WIRE OBSERVES ISTHMIC SEGMENT. NO REGIONAL COLLECTIONS. NO EXTRA UTERINE OR EXTRA TUBAL MIGRATION. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS : MENORRHAGIA, KIDNEY STONE, DYSMENORRHEA, ABDOMINAL PAIN MIGRAINE, MOOD SWINGS, PELVIC PAIN. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 17-APR-2019: PFS AND MR RECEIVED : REPORTER ADDED, AKA NAME ADDED, PATIENT DEMOGRAPHIC ADDED, ESSURE REMOVAL DATE ADDED. LOT NUMBER ADDED. CASE BECOME VALID. EVENT INJURY NOS IS REPLACED WITH EVENTS PELVIC PAIN, EMBEDDED DEVICE , MENORRHAGIA, VAGINAL HAEMORRHAGE, URINARY TRACT INFECTION , MIGRAINE, HEADACHE, DYSPAREUNIA, DYSMENORRHOEA, VAGINAL DISCHARGE, FATIGUE, NEPHROLITHIASIS, INSOMNIA, HOT FLUSH, MOOD ALTERED, MENTAL DISORDER, ABDOMINAL PAIN LOWER. EVENTS ONSET DATE, CONCOMITANT DRUG, MEDICAL HISTORY AND LAB DATA ADDED. WE RECEIVED A LOT NUMBER IN THIS CASE. A TECHNICAL INVESTIGATION WILL BE CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 346533 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | B04960-INV,804950-INV | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 36 YR | Other| R | ACETAMINOPHEN| ACETAMINOPHEN| ACETAMINOPHEN| ACETAMINOPHEN| ACETAMINOPHEN| ACETAMINOPHEN| ACETAMINOPHEN| ACETAMINOPHEN| ACETAMINOPHEN| CEPHALEXIN AMEL| CEPHALEXIN AMEL| CEPHALEXIN AMEL| CEPHALEXIN AMEL| CEPHALEXIN AMEL| CEPHALEXIN AMEL| CEPHALEXIN AMEL| CEPHALEXIN AMEL| CEPHALEXIN AMEL| FLONASE ALLERGY RELIEF| FLONASE ALLERGY RELIEF| FLONASE ALLERGY RELIEF| FLONASE ALLERGY RELIEF| FLONASE ALLERGY RELIEF| FLONASE ALLERGY RELIEF| FLONASE ALLERGY RELIEF| FLONASE ALLERGY RELIEF| FLONASE ALLERGY RELIEF| LEXAPRO| LEXAPRO| LEXAPRO| LEXAPRO| LEXAPRO| LEXAPRO| LEXAPRO| LEXAPRO| LEXAPRO| PHENAZOPYRIDINE| PHENAZOPYRIDINE| PHENAZOPYRIDINE| PHENAZOPYRIDINE| PHENAZOPYRIDINE| PHENAZOPYRIDINE| PHENAZOPYRIDINE| PHENAZOPYRIDINE| PHENAZOPYRIDINE| WELLBUTRIN| WELLBUTRIN| WELLBUTRIN| WELLBUTRIN| WELLBUTRIN| WELLBUTRIN| WELLBUTRIN| XANAX| XANAX| XANAX| XANAX| XANAX| XANAX| XANAX| ACETAMINOPHEN| CEPHALEXIN AMEL| FLONASE ALLERGY RELIEF| LEXAPRO| PHENAZOPYRIDINE |