ESSURE
Report
- Report Number
- 2951250-2017-03635
- Event Type
- Injury
- Date Received
- September 14, 2017
- Date of Event
- January 1, 2014
- Report Date
- June 18, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ("MIGRATION OF THE DEVICE") AND PELVIC PAIN ("PELVIC PAIN / PAIN") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 834599 INVALID) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "DID NOT UNDERGO AN ESSURE CONFIRMATION TEST". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED NEPHRECTOMY IN 2008. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR BIRTH CONTROL: IUD PARAGUARD IN (B)(6) 2013. CONCURRENT CONDITIONS INCLUDED BLOATING, STOMACH DISCOMFORT (RANGES FROM CLEAR TO YELLOWISH), VAGINAL DISCHARGE, GESTATIONAL DIABETES MELLITUS, CRAMP IN LOWER ABDOMEN, VAGINAL BLEEDING, FATIGUE, UTERINE CRAMPS, FIBROIDS, DYSFUNCTIONAL UTERINE BLEEDING, DYSMENORRHEA, MIGRAINE, HEADACHE, ABDOMINAL PAIN (PATIENT COMPLAINS OF ABDOMINAL PAIN. SHE HAS BELIEVES IS RELATED TO HER PROCEDURE) AND FLANK PAIN. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENSTRUAL DISORDER ("MENSTRUATION ISSUES"), MENOMETRORRHAGIA ("MENOMETRORRHAGIA"), CYST ("A CYST"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING ( MENORRHAGIA)") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). THE PATIENT WAS TREATED WITH SURGERY (FULL HYSTERECTOMY WITH BILATERAL SALPINGECTOMY AND OOPHORECTOMY ON (B)(6) 2015) AND SURGERY (UNDERWENT A HYSTEROSCOPY, TOTAL LAPAROSCOPIC HYSTERECTOMY). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, PELVIC PAIN, MENSTRUAL DISORDER, MENOMETRORRHAGIA, CYST, VAGINAL HAEMORRHAGE, MENORRHAGIA AND VAGINAL DISCHARGE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED CYST, DEVICE DISLOCATION, MENOMETRORRHAGIA, MENORRHAGIA, MENSTRUAL DISORDER, PELVIC PAIN, VAGINAL DISCHARGE AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THE PATIENT TOLERATED THE PROCEDURE WELL. SHE EXPERIENCED DECREASE OF PAIN SHORTLY AFTER ESSURE REMOVAL. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: MENORRHAGIA, PELVIC PAIN, MENOMETRORRHAGIA. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 26-JUL-2018: QUALITY DEPARTMENT MENTIONED THAT THE REPORTED LOT NUMBER 834599 WAS INVALID. FDA CODES WERE ADDED. INCIDENT: NO VALID LOT NUMBER OR SAMPLE AVAILABLE FOR INVESTIGATION. THERE IS NO EVIDENCE THAT A DEVICE RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ("MIGRATION OF THE DEVICE") AND PELVIC PAIN ("PELVIC PAIN / PAIN") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 834599) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "DID NOT UNDERGO AN ESSURE CONFIRMATION TEST". ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENSTRUAL DISORDER ("MENSTRUATION ISSUES"), MENOMETRORRHAGIA ("MENOMETRORRHAGIA"), CYST ("A CYST"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND MENORRHAGIA ("ABNORMAL BLEEDING ( MENORRHAGIA)"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY) AND SURGERY (UNDERWENT A HYSTEROSCOPY, TOTAL LAPAROSCOPIC HYSTERECTOMY). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, PELVIC PAIN, MENSTRUAL DISORDER, MENOMETRORRHAGIA, CYST, VAGINAL HAEMORRHAGE AND MENORRHAGIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED CYST, DEVICE DISLOCATION, MENOMETRORRHAGIA, MENORRHAGIA, MENSTRUAL DISORDER, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: PFS RECEIVED - NEW EVENT "ABNORMAL BLEEDING (VAGINAL), ABNORMAL BLEEDING ( MENORRHAGIA),DID NOT UNDERGO AN ESSURE CONFIRMATION TEST" WERE ADDED. LOT NUMBER WAS ADDED. PRODUCT IMPLANT DATE WAS UPDATED. INCIDENT: AT THE TIME OF REPORTING, THERE IS NO EVIDENCE THAT A DEVICE-RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ("MIGRATION OF THE DEVICE") AND PELVIC PAIN ("PELVIC PAIN / PAIN") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 834599) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "DID NOT UNDERGO AN ESSURE CONFIRMATION TEST". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED NEPHRECTOMY IN 2008. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR BIRTH CONTROL: IUD PARAGUARD IN (B)(6) 2013. CONCURRENT CONDITIONS INCLUDED BLOATING, STOMACH DISCOMFORT (RANGES FROM CLEAR TO YELLOWISH), VAGINAL DISCHARGE, GESTATIONAL DIABETES MELLITUS, CRAMP IN LOWER ABDOMEN, VAGINAL BLEEDING, FATIGUE, UTERINE CRAMPS, FIBROIDS, DYSFUNCTIONAL UTERINE BLEEDING, DYSMENORRHEA, MIGRAINE, HEADACHE, ABDOMINAL PAIN (PATIENT COMPLAINS OF ABDOMINAL PAIN. SHE HAS BELIEVES IS RELATED TO HER PROCEDURE) AND FLANK PAIN. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENSTRUAL DISORDER ("MENSTRUATION ISSUES"), MENOMETRORRHAGIA ("MENOMETRORRHAGIA"), CYST ("A CYST"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING ( MENORRHAGIA)") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). THE PATIENT WAS TREATED WITH SURGERY (FULL HYSTERECTOMY WITH BILATERAL SALPINGECTOMYAND OOPHORECTOMY ON (B)(6) 2015) AND SURGERY (UNDERWENT A HYSTEROSCOPY, TOTAL LAPAROSCOPIC HYSTERECTOMY). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, PELVIC PAIN, MENSTRUAL DISORDER, MENOMETRORRHAGIA, CYST, VAGINAL HAEMORRHAGE, MENORRHAGIA AND VAGINAL DISCHARGE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED CYST, DEVICE DISLOCATION, MENOMETRORRHAGIA, MENORRHAGIA, MENSTRUAL DISORDER, PELVIC PAIN, VAGINAL DISCHARGE AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THE PATIENT TOLERATED THE PROCEDURE WELL. SHE EXPERIENCED DECREASE OF PAIN SHORTLY AFTER ESSURE REMOVAL. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: MENORRHAGIA, PELVIC PAIN, MENOMETRORRHAGIA MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 17-MAY-2018: PFS RECEIVED: EVENT VAGINAL DISCHARGE ADDED. REMOVAL PROCEDURE UPDATED TO HYSTERECTOMY, BILATERAL SALPINGECTOMY AND OOPHORECTOMY. INCIDENT: AT THE TIME OF REPORTING, THERE IS NO EVIDENCE THAT A DEVICE-RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ("MIGRATION OF THE DEVICE") AND PELVIC PAIN ("PELVIC PAIN / PAIN") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 834599-INVALID) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "DID NOT UNDERGO AN ESSURE CONFIRMATION TEST". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED NEPHRECTOMY IN 2008. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR BIRTH CONTROL: IUD PARAGUARD IN (B)(6) 2013. CONCURRENT CONDITIONS INCLUDED BLOATING, STOMACH DISCOMFORT (RANGES FROM CLEAR TO YELLOWISH), VAGINAL DISCHARGE, GESTATIONAL DIABETES MELLITUS, CRAMP IN LOWER ABDOMEN, VAGINAL BLEEDING, FATIGUE, UTERINE CRAMPS, FIBROIDS, DYSFUNCTIONAL UTERINE BLEEDING, DYSMENORRHEA, MIGRAINE, HEADACHE, ABDOMINAL PAIN (PATIENT COMPLAINS OF ABDOMINAL PAIN. SHE HAS BELIEVES IS RELATED TO HER PROCEDURE) AND FLANK PAIN. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENSTRUAL DISORDER ("MENSTRUATION ISSUES"), MENOMETRORRHAGIA ("MENOMETRORRHAGIA"), CYST ("A CYST"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING ( MENORRHAGIA)") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). THE PATIENT WAS TREATED WITH SURGERY (FULL HYSTERECTOMY WITH BILATERAL SALPINGECTOMYAND OOPHORECTOMY ON (B)(6) 2015) AND SURGERY (UNDERWENT A HYSTEROSCOPY, TOTAL LAPAROSCOPIC HYSTERECTOMY). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, PELVIC PAIN, MENSTRUAL DISORDER, MENOMETRORRHAGIA, CYST, VAGINAL HAEMORRHAGE, MENORRHAGIA AND VAGINAL DISCHARGE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED CYST, DEVICE DISLOCATION, MENOMETRORRHAGIA, MENORRHAGIA, MENSTRUAL DISORDER, PELVIC PAIN, VAGINAL DISCHARGE AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THE PATIENT TOLERATED THE PROCEDURE WELL. SHE EXPERIENCED DECREASE OF PAIN SHORTLY AFTER ESSURE REMOVAL. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: MENORRHAGIA, PELVIC PAIN, MENOMETRORRHAGIA . QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 8-AUG-2018: QUALITY-SAFETY EVALUATION OF PTC (PRODUCT TECHNICAL COMPLAINT). INCIDENT : NO VALID LOT NUMBER OR SAMPLE AVAILABLE FOR INVESTIGATION. THERE IS NO EVIDENCE THAT A DEVICE RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE EXPULSION ("MIGRATION OF THE DEVICE / MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: UTERUS"), PELVIC PAIN ("PELVIC PAIN / PAIN"), RENAL FAILURE ("KIDNEY FAILURE /") AND KIDNEY PERFORATION ("KIDNEY PERFORATION") IN A 30-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 834599-INVALID) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "DID NOT UNDERGO AN ESSURE CONFIRMATION TEST". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED NEPHRECTOMY IN 2008, MISCARRIAGE AND PREMATURE DELIVERY. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR BIRTH CONTROL: IUD PARAGUARD IN AUGUST 2013; FOR AN UNREPORTED INDICATION: ORAL CONTRACEPTIVE NOS. CONCURRENT CONDITIONS INCLUDED BLOATING, STOMACH DISCOMFORT (RANGES FROM CLEAR TO YELLOWISH), VAGINAL DISCHARGE, GESTATIONAL DIABETES MELLITUS, CRAMP IN LOWER ABDOMEN, VAGINAL BLEEDING, FATIGUE, UTERINE CRAMPS, FIBROIDS, DYSFUNCTIONAL UTERINE BLEEDING, DYSMENORRHEA, MIGRAINE, HEADACHE, ABDOMINAL PAIN (PATIENT COMPLAINS OF ABDOMINAL PAIN. SHE HAS BELIEVES IS RELATED TO HER PROCEDURE) AND FLANK PAIN. CONCOMITANT PRODUCTS INCLUDED AMOXICILLIN (AMOXIL), CENTRUM, ESCITALOPRAM OXALATE (LEXAPRO), IBUPROFEN, MACRO-B, METFORMIN, NIFEDIPINE (PROCARDIA), PANADEINE CO (TYLENOL #3), PHENAZOPYRIDINE HYDROCHLORIDE (PYRIDIUM) AND TRAMADOL. ON 30-DEC-2013, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2014, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND FATIGUE ("FATIGUE"). IN FEBRUARY 2014, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND MENORRHAGIA ("ABNORMAL BLEEDING ( MENORRHAGIA)"). IN (B)(6) 2014, THE PATIENT EXPERIENCED NAUSEA ("NAUSEA"). ON (B)(6) 2014, 1 YEAR AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON (B)(6) 2015, THE PATIENT EXPERIENCED DEPRESSION ("DEPRESSION"), ANXIETY ("MENTAL ANGUISH") AND RENAL FAILURE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED MENSTRUAL DISORDER ("MENSTRUATION ISSUES"), MENOMETRORRHAGIA ("MENOMETRORRHAGIA"), CYST ("A CYST"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), BACK PAIN ("LOWER BACK PAIN"), KIDNEY PERFORATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DIZZINESS ("FEELING DIZZY") AND VOMITING ("STARTED VOMITING BROWN LIQUID"). THE PATIENT WAS TREATED WITH SURGERY (FULL HYSTERECTOMY WITH BILATERAL SALPINGECTOMYAND OOPHORECTOMY ON (B)(6) 2015), SURGERY (UNDERWENT A HYSTEROSCOPY, TOTAL LAPAROSCOPIC HYSTERECTOMY) AND SURGERY (EMERGENCY KIDNEY REPAIR SURGERY). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE DEVICE EXPULSION, PELVIC PAIN, VAGINAL HAEMORRHAGE, MENORRHAGIA, DEPRESSION, ANXIETY, MIGRAINE, HEADACHE, NAUSEA, DYSMENORRHOEA, DYSPAREUNIA, RENAL FAILURE, FATIGUE AND BACK PAIN HAD RESOLVED AND THE MENSTRUAL DISORDER, MENOMETRORRHAGIA, CYST, VAGINAL DISCHARGE, KIDNEY PERFORATION, DIZZINESS AND VOMITING OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ANXIETY, BACK PAIN, CYST, DEPRESSION, DEVICE EXPULSION, DIZZINESS, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, HEADACHE, KIDNEY PERFORATION, MENOMETRORRHAGIA, MENORRHAGIA, MENSTRUAL DISORDER, MIGRAINE, NAUSEA, PELVIC PAIN, RENAL FAILURE, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND VOMITING TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THE PATIENT TOLERATED THE PROCEDURE WELL. SHE EXPERIENCED DECREASE OF PAIN SHORTLY AFTER ESSURE REMOVAL. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2013: TOTAL BILATERAL OCCLUSION. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: MENORRHAGIA, PELVIC PAIN, MENOMETRORRHAGIA. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 28-AUG-2018: EVENTS- "DEPRESSION, MENTAL ANGUISH, MIGRAINES, HEADACHES, NAUSEA, DYSMENORRHEA (CRAMPING), DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), KIDNEY FAILURE, FATIGUE, LOWER BACK PAIN, KIDNEY PERFORATION, FEELING DIZZY, STARTED VOMITING BROWN LIQUID" ADDED, PREVIOUSLY REPORTED EVENT "MIGRATION OF THE DEVICE" PT UPDATED TO "DEVICE EXPULSION" , CONCOMITANT DRUG, LAB DATA ADDED FROM PFS. INCIDENT NO VALID LOT NUMBER OR SAMPLE AVAILABLE FOR INVESTIGATION. THERE IS NO EVIDENCE THAT A DEVICE RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE EXPULSION ('MIGRATION OF THE DEVICE / MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: UTERUS'), PELVIC PAIN ('PELVIC PAIN / PAIN'), RENAL FAILURE ('KIDNEY FAILURE /') AND KIDNEY PERFORATION ('KIDNEY PERFORATION') IN A 30-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 834599-NOT VALID) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "DID NOT UNDERGO AN ESSURE CONFIRMATION TEST". THE PATIENT'S MEDICAL HISTORY INCLUDED NEPHRECTOMY IN 2008, MISCARRIAGE AND PREMATURE DELIVERY. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR BIRTH CONTROL: IUD PARAGUARD; FOR AN UNREPORTED INDICATION: ORAL CONTRACEPTIVE NOS. CONCURRENT CONDITIONS INCLUDED BLOATING, STOMACH DISCOMFORT (RANGES FROM CLEAR TO YELLOWISH), VAGINAL DISCHARGE, GESTATIONAL DIABETES MELLITUS, CRAMP IN LOWER ABDOMEN, VAGINAL BLEEDING, FATIGUE, UTERINE CRAMPS, FIBROIDS, DYSFUNCTIONAL UTERINE BLEEDING, DYSMENORRHEA, MIGRAINE, HEADACHE, ABDOMINAL PAIN (PATIENT COMPLAINS OF ABDOMINAL PAIN. SHE HAS BELIEVES IS RELATED TO HER PROCEDURE), FLANK PAIN, NEPHROLITHIASIS, KIDNEY STONE AND NEPHRECTOMY. CONCOMITANT PRODUCTS INCLUDED AMOXICILLIN (AMOXIL), CODEINE PHOSPHATE;PARACETAMOL (TYLENOL WITH CODEINE NO.3), ESCITALOPRAM OXALATE (LEXAPRO), IBUPROFEN, METFORMIN, MINERALS NOS;VITAMINS NOS (CENTRUM), PHENAZOPYRIDINE HYDROCHLORIDE (PYRIDIUM), TRAMADOL AND VITAMINS NOS (MACRO-B). ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2014, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING ( MENORRHAGIA)"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND FATIGUE ("FATIGUE"). IN (B)(6) 2014, THE PATIENT EXPERIENCED DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS - CONDITION: DEPRESSION/PSYCH INJURY") AND ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS - CONDITION: MENTAL ANGUISH"), 1 YEAR 2 MONTHS AFTER INSERTION OF ESSURE. IN (B)(6) 2014, THE PATIENT EXPERIENCED NAUSEA ("NAUSEA"). ON (B)(6) 2014, THE PATIENT EXPERIENCED DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON (B)(6) 2015, THE PATIENT EXPERIENCED RENAL FAILURE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED MENSTRUAL DISORDER ("MENSTRUATION ISSUES"), MENOMETRORRHAGIA ("MENOMETRORRHAGIA"), CYST ("A CYST"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), BACK PAIN ("LOWER BACK PAIN"), KIDNEY PERFORATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DIZZINESS ("FEELING DIZZY"), DISCOLOURED VOMIT ("STARTED VOMITING BROWN LIQUID"), METRORRHAGIA ("METRORRHAGIA") AND POST PROCEDURAL COMPLICATION ("POST REMOVAL COMPLICATIONS"). THE PATIENT WAS TREATED WITH SURGERY (FULL HYSTERECTOMY WITH BILATERAL SALPINGECTOMY AND OOPHORECTOMY ON (B)(6) 2015, EMERGENCY KIDNEY REPAIR SURGERY AND UNDERWENT A HYSTEROSCOPY, TOTAL LAPAROSCOPIC HYSTERECTOMY). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE DEVICE EXPULSION, PELVIC PAIN, VAGINAL HAEMORRHAGE, MENORRHAGIA, DEPRESSION, ANXIETY, MIGRAINE, HEADACHE, NAUSEA, DYSMENORRHOEA, DYSPAREUNIA, RENAL FAILURE, FATIGUE, BACK PAIN AND METRORRHAGIA HAD RESOLVED AND THE MENSTRUAL DISORDER, MENOMETRORRHAGIA, CYST, VAGINAL DISCHARGE, KIDNEY PERFORATION, DIZZINESS, DISCOLOURED VOMIT AND POST PROCEDURAL COMPLICATION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ANXIETY, BACK PAIN, CYST, DEPRESSION, DEVICE EXPULSION, DISCOLOURED VOMIT, DIZZINESS, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, HEADACHE, KIDNEY PERFORATION, MENOMETRORRHAGIA, MENORRHAGIA, MENSTRUAL DISORDER, METRORRHAGIA, MIGRAINE, NAUSEA, PELVIC PAIN, POST PROCEDURAL COMPLICATION, RENAL FAILURE, VAGINAL DISCHARGE AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THE PATIENT TOLERATED THE PROCEDURE WELL. SHE EXPERIENCED DECREASE OF PAIN SHORTLY AFTER ESSURE REMOVAL. DISCREPANCY IN ESSURE REMOVAL DATE: (B)(6) 2015. HYSTERECTOMY WITH UNILATERAL SALPINGECTOMY ¿ RIGHT SALPINGECTOMY ON (B)(6) 2015. SHE HAD RECEIVED TREATMENT FOR "PAIN, BLEEDING AND MIGRATION". DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 73.8 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2013: RESULTS: TOTAL BILATERAL OCCLUSION; ON (B)(6) 2014: TOTAL BILATERAL OCCLUSION.. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: MENORRHAGIA, PELVIC PAIN, MENOMETRORRHAGIA. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2020: PLAINTIFF INFORMATION FORM RECEIVED. EVENT¿ METRORRHAGIA AND POST PROCEDURAL COMPLICATION¿ 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 EXPULSION ('MIGRATION OF THE DEVICE / MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: UTERUS'), PELVIC PAIN ('PELVIC PAIN / PAIN'), RENAL FAILURE ('KIDNEY FAILURE /') AND KIDNEY PERFORATION ('KIDNEY PERFORATION') IN A 30-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 834599-NOT VALID) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "DID NOT UNDERGO AN ESSURE CONFIRMATION TEST". THE PATIENT'S MEDICAL HISTORY INCLUDED NEPHRECTOMY IN 2008, MISCARRIAGE AND PREMATURE DELIVERY. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR BIRTH CONTROL: IUD PARAGUARD; FOR AN UNREPORTED INDICATION: ORAL CONTRACEPTIVE NOS. CONCURRENT CONDITIONS INCLUDED BLOATING, STOMACH DISCOMFORT (RANGES FROM CLEAR TO YELLOWISH), VAGINAL DISCHARGE, GESTATIONAL DIABETES MELLITUS, CRAMP IN LOWER ABDOMEN, VAGINAL BLEEDING, FATIGUE, UTERINE CRAMPS, FIBROIDS, DYSFUNCTIONAL UTERINE BLEEDING, DYSMENORRHEA, MIGRAINE, HEADACHE, ABDOMINAL PAIN (PATIENT COMPLAINS OF ABDOMINAL PAIN. SHE HAS BELIEVES IS RELATED TO HER PROCEDURE), FLANK PAIN, NEPHROLITHIASIS, KIDNEY STONE AND NEPHRECTOMY. CONCOMITANT PRODUCTS INCLUDED AMOXICILLIN (AMOXIL), CODEINE PHOSPHATE;PARACETAMOL (TYLENOL WITH CODEINE NO.3), ESCITALOPRAM OXALATE (LEXAPRO), IBUPROFEN, METFORMIN, MINERALS NOS;VITAMINS NOS (CENTRUM), PHENAZOPYRIDINE HYDROCHLORIDE (PYRIDIUM), TRAMADOL AND VITAMINS NOS (MACRO-B). ON 30-DEC-2013, THE PATIENT HAD ESSURE INSERTED. IN JANUARY 2014, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING ( MENORRHAGIA)"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND FATIGUE ("FATIGUE"). IN FEBRUARY 2014, THE PATIENT EXPERIENCED DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS - CONDITION: DEPRESSION/PSYCH INJURY") AND ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS - CONDITION: MENTAL ANGUISH"), 1 YEAR 2 MONTHS AFTER INSERTION OF ESSURE. IN FEBRUARY 2014, THE PATIENT EXPERIENCED NAUSEA ("NAUSEA"). ON 31-DEC-2014, THE PATIENT EXPERIENCED DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON 16-MAR-2015, THE PATIENT EXPERIENCED RENAL FAILURE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED MENSTRUAL DISORDER ("MENSTRUATION ISSUES"), MENOMETRORRHAGIA ("MENOMETRORRHAGIA"), CYST ("A CYST"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), BACK PAIN ("LOWER BACK PAIN"), KIDNEY PERFORATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DIZZINESS ("FEELING DIZZY"), DISCOLOURED VOMIT ("STARTED VOMITING BROWN LIQUID"), METRORRHAGIA ("METRORRHAGIA") AND POST PROCEDURAL COMPLICATION ("POST REMOVAL COMPLICATIONS"). THE PATIENT WAS TREATED WITH SURGERY (FULL HYSTERECTOMY WITH BILATERAL SALPINGECTOMYAND OOPHORECTOMY ON 06-MAR-2015, EMERGENCY KIDNEY REPAIR SURGERY AND UNDERWENT A HYSTEROSCOPY, TOTAL LAPAROSCOPIC HYSTERECTOMY). ESSURE WAS REMOVED ON 16-MAR-2015. AT THE TIME OF THE REPORT, THE DEVICE EXPULSION, PELVIC PAIN, VAGINAL HAEMORRHAGE, MENORRHAGIA, DEPRESSION, ANXIETY, MIGRAINE, HEADACHE, NAUSEA, DYSMENORRHOEA, DYSPAREUNIA, RENAL FAILURE, FATIGUE, BACK PAIN AND METRORRHAGIA HAD RESOLVED AND THE MENSTRUAL DISORDER, MENOMETRORRHAGIA, CYST, VAGINAL DISCHARGE, KIDNEY PERFORATION, DIZZINESS, DISCOLOURED VOMIT AND POST PROCEDURAL COMPLICATION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ANXIETY, BACK PAIN, CYST, DEPRESSION, DEVICE EXPULSION, DISCOLOURED VOMIT, DIZZINESS, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, HEADACHE, KIDNEY PERFORATION, MENOMETRORRHAGIA, MENORRHAGIA, MENSTRUAL DISORDER, METRORRHAGIA, MIGRAINE, NAUSEA, PELVIC PAIN, POST PROCEDURAL COMPLICATION, RENAL FAILURE, VAGINAL DISCHARGE AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THE PATIENT TOLERATED THE PROCEDURE WELL. SHE EXPERIENCED DECREASE OF PAIN SHORTLY AFTER ESSURE REMOVAL. DISCREPANCY IN ESSURE REMOVAL DATE: (B)(6) 2015. HYSTERECTOMY WITH UNILATERAL SALPINGECTOMY ¿ RIGHT SALPINGECTOMY ON (B)(6) 2015. SHE HAD RECEIVED TREATMENT FOR "PAIN, BLEEDING AND MIGRATION". DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 73.8 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2013: RESULTS: TOTAL BILATERAL OCCLUSION; ON 01-MAR-2014: TOTAL BILATERAL OCCLUSION.. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: MENORRHAGIA, PELVIC PAIN, MENOMETRORRHAGIA. 834599-NOT VALID QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2020: QUALITY SAFETY EVALUATION. OF PTC 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 PELVIC PAIN ("PELVIC PAIN") AND DEVICE DISLOCATION ("MIGRATION OF THE DEVICE") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENSTRUAL DISORDER ("MENSTRUATION ISSUES"), MENOMETRORRHAGIA ("MENOMETRORRHAGIA") AND CYST ("A CYST"). THE PATIENT WAS TREATED WITH SURGERY (UNDERWENT A HYSTEROSCOPY, TOTAL LAPAROSCOPIC HYSTERECTOMY ) AND SURGERY (HYSTEROSCOPY, TOTAL LAPAROSCOPIC HYSTERECTOMY AND A RIGHT SALPINGECTOMY DUE TO COMPLICATIONS). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE PELVIC PAIN, DEVICE DISLOCATION, MENSTRUAL DISORDER, MENOMETRORRHAGIA AND CYST OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED CYST, DEVICE DISLOCATION, MENOMETRORRHAGIA, MENSTRUAL DISORDER AND PELVIC PAIN TO BE RELATED TO ESSURE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 28-AUG-2017: NEW EVENTS 'MIGRATION OF THE DEVICE', 'A CYST', AND 'MENOMETRORRHAGIA' WERE ADDED. DATE OF ESSURE INSERTION WAS UPDATED. INCIDENT: NO LOT NUMBER OR SAMPLE AVAILABLE FOR INVESTIGATION. THERE IS NO EVIDENCE THAT A DEVICE RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PELVIC PAIN") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND MENSTRUAL DISORDER ("MENSTRUATION ISSUES"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH SALPINGECTOMY DUE TO COMPLICATIONS). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE PELVIC PAIN AND MENSTRUAL DISORDER OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED MENSTRUAL DISORDER AND PELVIC PAIN TO BE RELATED TO ESSURE. INCIDENT. NO LOT NUMBER OR SAMPLE AVAILABLE FOR INVESTIGATION. THERE IS NO EVIDENCE THAT A DEVICE RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 645242 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 834599-NOT VALID |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 30 YR | Other| R | AMOXIL| AMOXIL [AMOXICILLIN]| AMOXIL [AMOXICILLIN]| CENTRUM| CENTRUM [MINERALS NOS,VITAMINS NOS]| CENTRUM [MINERALS NOS,VITAMINS NOS]| IBUPROFEN| IBUPROFEN| IBUPROFEN| LEXAPRO| LEXAPRO| LEXAPRO| MACRO-B| MACRO-B| MACRO-B| METFORMIN| METFORMIN| METFORMIN| OTHER THERAPEUTIC PRODUCTS| OTHER THERAPEUTIC PRODUCTS| PROCARDIA| PYRIDIUM| PYRIDIUM| PYRIDIUM| TRAMADOL| TRAMADOL| TRAMADOL| TYLENOL #3| TYLENOL WITH CODEINE NO.3| TYLENOL WITH CODEINE NO.3 |