ESSURE
Report
- Report Number
- 2951250-2018-01364
- Event Type
- Injury
- Date Received
- March 30, 2018
- Date of Event
- July 20, 2011
- Report Date
- August 19, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PAIN / PAIN SEVERE AND PERSISTENT PAIN / LOWER STOMACH PAIN- FELT LIKE I WAS IN LABOR PAIN'), BLADDER PERFORATION ('PERFORATION (DOCTOR NICKED THE BLADDER WHEN REMOVING UTERUS) / BLADDER INJURY DURING HEMATOMA EVACUATION SURGERY ON (B)(6) 2013') AND HAEMATOMA EVACUATION ('EVACUATION HEMATOMA') IN A 26-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 841528) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED GRAVIDA I, PARITY 1 (B)(6)2009), C-SECTION, FIBROMYALGIA, HERNIATED DISC, UTERINE DILATION AND CURETTAGE, NORMAL DELIVERY (LIVE CHILD) AND ANEMIA. * ON (B)(6)2011, DYE TEST RESULTED THEY WERE IN AND TUBES WERE OCCULTED DATE: (B)(6)2011 TYPE OF TEST: - DYE TEST RESULT: THEY WERE IN AND FINE. DATE OF RESULT: (B)(6)2011. DATE: (B)(6)2011 TYPE OF TEST: - DYE TEST RESULT: THEY WERE IN AND FINE. DATE OF RESULT: (B)(6)2011. (DISCREPANCY BETWEEN TWO PFS NOTED). PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: DEPO-PROVERA FROM (B)(6)2010 TO (B)(6)2013 AND BIRTH CONTROL PILLS FROM (B)(6)2009 TO (B)(6)2010. CONCURRENT CONDITIONS INCLUDED BODY MASS INDEX NORMAL, PENICILLIN ALLERGY, DYSMENORRHEA, PRURITUS, MENSES IRREGULAR, UTI, VAGINAL DRYNESS, DYSURIA AND PERITONEAL HEMATOMA. CONCOMITANT PRODUCTS INCLUDED BUSPIRONE, ESCITALOPRAM OXALATE (LEXAPRO), NSAIDS, OXYCODONE HYDROCHLORIDE;PARACETAMOL (PERCOCET), PARACETAMOL (TYLENOL) AND PARACETAMOL + CAFFEINE + PYRILAMINE MALEATE (MIDOL COMPLETE FORMULA CAPLETS). ON (B)(6)2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6)2011, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON (B)(6)2011, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE ("HEAVY BLEEDING/ ABNORMAL BLEEDING"), DERMATITIS ALLERGIC ("ALLERGIC/HYPERSENSITIVITY: RASHES") AND URTICARIA ("ALLERGIC/HYPERSENSITIVITY HIVES INSIDE OF MY THIGHS"). IN (B)(6)2011, THE PATIENT EXPERIENCED ALLERGY TO METALS ("NICKEL ALLERGY"). IN (B)(6)2011, THE PATIENT EXPERIENCED FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)") AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). IN (B)(6)2011, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"). ON (B)(6)2011, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE"), DEPRESSION ("DEPRESSION") AND ANXIETY ("ANXIETY") AND WAS FOUND TO HAVE WEIGHT INCREASED ("HORMONAL CHANGES: WEIGHT GAIN"). IN (B)(6)2012, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES") AND HEADACHE ("HEADACHES"). IN (B)(6)2013, THE PATIENT EXPERIENCED HOT FLUSH ("HORMONAL CHANGES- HOT FLASHES"). IN (B)(6)2013, THE PATIENT EXPERIENCED MENORRHAGIA ("MENORRHAGIA/ HEAVY BLEEDING"). ON (B)(6)2013, THE PATIENT UNDERWENT HAEMATOMA EVACUATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND EXPERIENCED BLADDER DISORDER ("BLADDER PROBLEM"), PREMATURE MENOPAUSE ("I FEEL LIKE I AM IN EARLY MENOPAUSE NOS") AND BLADDER INJURY ("BLADDER INJURY DURING HEMATOMA EVACUATION SURGERY ON"). ON (B)(6)2014, THE PATIENT EXPERIENCED DENTAL CARIES ("DENTAL PROBLEMS : TEETH DECAY") AND TOOTH LOSS ("TEETH FALLING OUT / DENTAL PROBLEMS FALLING OUT"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED BLADDER PERFORATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), URINARY TRACT DISORDER ("URINARY PROBLEM"), COMPLICATION OF DEVICE REMOVAL ("COMPLICATION OF DEVICE REMOVAL"), ABDOMINAL PAIN ("ABDOMEN PAIN"), DYSFUNCTIONAL UTERINE BLEEDING ("DYSFUNCTIONAL UTERINE BLEEDING") AND DYSMENORRHOEA ("DYSMENORRHEA"). THE PATIENT WAS TREATED WITH DULOXETINE HYDROCHLORIDE (CYMBALTA), IBUPROFEN, TRAZODONE, REMOVED TOP TEETH / PARTIAL DENTURES AND SURGERY (LAPAROSCOPIC EVACUATION OF HEMATOMA ON (B)(6)2013 AND TOTAL ABDOMINAL HYSTERECTOMY, RIGHT SALPINGECTOMY AND LEFT PARTIAL SALPINGECTOMY AND ESSURE REMOVAL). ESSURE WAS REMOVED ON (B)(6)2013. AT THE TIME OF THE REPORT, THE PELVIC PAIN, BLADDER PERFORATION, GENITAL HAEMORRHAGE, MENORRHAGIA, DERMATITIS ALLERGIC, URTICARIA, FEMALE SEXUAL DYSFUNCTION, BLADDER DISORDER, URINARY TRACT DISORDER, DENTAL CARIES, DYSPAREUNIA, FATIGUE, HOT FLUSH, WEIGHT INCREASED, HEADACHE, ALLERGY TO METALS AND DEPRESSION HAD NOT RESOLVED, THE HAEMATOMA EVACUATION, ANXIETY, TOOTH LOSS, COMPLICATION OF DEVICE REMOVAL, PREMATURE MENOPAUSE, BLADDER INJURY, ABDOMINAL PAIN, DYSFUNCTIONAL UTERINE BLEEDING AND DYSMENORRHOEA OUTCOME WAS UNKNOWN, THE VAGINAL HAEMORRHAGE HAD RESOLVED AND THE MIGRAINE WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALLERGY TO METALS, ANXIETY, BLADDER DISORDER, BLADDER INJURY, BLADDER PERFORATION, COMPLICATION OF DEVICE REMOVAL, DENTAL CARIES, DEPRESSION, DERMATITIS ALLERGIC, DYSFUNCTIONAL UTERINE BLEEDING, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GENITAL HAEMORRHAGE, HAEMATOMA EVACUATION, HEADACHE, HOT FLUSH, MENORRHAGIA, MIGRAINE, PELVIC PAIN, PREMATURE MENOPAUSE, TOOTH LOSS, URINARY TRACT DISORDER, URTICARIA, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE REPORTED HER SYMPTOMS, INCLUDING BLEEDING AND PAIN. THE PHYSICIAN WANTED TO DO A D+C; SINCE SHE WAS STILL HAVING PAIN THEY DISCUSSED REMOVAL OF HER UTERUS. STATUS POST TOTAL ABDOMINAL HYSTERECTOMY WITH RIGHT SALPINGECTOMY ON (B)(6)2013 : THE PATIENT WAS FOUND TO DEVELOP AN INTRAPERITONEAL BLEED AND WAS TAKEN TO THE OPERATING ROOM AGAIN ON (B)(6)2013 FOR EXPLORATORY LAPAROTOMY, EVACUATION OF HEMATOMA, AND SUTURING OF BLEEDERS. (DISCREPANCY BETWEEN TWO PFS NOTED). DATE(S) OF INSERTION: (B)(6)2011 AND (B)(6)2011(DISCREPANCY BETWEEN TWO PFS NOTED) DATE(S) (DISCREPANCY BETWEEN TWO PFS NOTED) DATE: (B)(6)2011. TYPE OF TEST: - DYE TEST RESULT: THEY WERE IN AND FINE. DATE OF RESULT: (B)(6)2011 DATE: (B)(6)2011. TYPE OF TEST: - DYE TEST RESULT: THEY WERE IN AND FINE. DATE OF RESULT: (B)(6)2011 (DISCREPANCY BETWEEN TWO PFS NOTED) . DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 19 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6)2011: TOTAL BILATERAL OCCLUSION. COMPLETE OCCLUSION OF THE FALLOPIAN TUBES BY THE ESSURE WIRES.. PREGNANCY TEST - ON AN UNKNOWN DATE: NEGATIVE.. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS: MENORRHAGIA, PELVIC PAIN. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 14-AUG-2020: QUALITY-SAFETY EVALUATION OF PTC. A TECHNICAL INVESTIGATION WAS 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.
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN"), BLADDER PERFORATION ("PERFORATION (DOCTOR NICKED THE BLADDER WHEN REMOVING UTERUS)"), GENITAL HAEMORRHAGE ("HEAVY BLEEDING/ ABNORMAL BLEEDING") AND HAEMATOMA EVACUATION ("EVACUATION HEMATOMA") IN A 26-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 841528) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED GRAVIDA I, PARITY 1 (B)(6) 2009), C-SECTION, FIBROMYALGIA AND HERNIATED DISC. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: DEPO-PROVERA FROM MARCH 2010 TO SEPTEMBER 2013 AND BIRTH CONTROL PILLS FROM NOVEMBER 2009 TO MARCH 2010. CONCURRENT CONDITIONS INCLUDED MORBID OBESITY AND PENICILLIN ALLERGY. CONCOMITANT PRODUCTS INCLUDED BUSPIRONE, ESCITALOPRAM OXALATE (LEXAPRO) AND OXYCOCET (PERCOCET). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2011, 14 DAYS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), RASH ("ALLERGIC/HYPERSENSITIVITY: RASHES") AND URTICARIA ("ALLERGIC/HYPERSENSITIVITY HIVES INSIDE OF MY THIGHS"). IN AUGUST 2011, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGNIAL)"). ON (B)(6) 2011, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE"), WEIGHT INCREASED ("HORMONAL CHANGES: WEIGHT GAIN"), ALLERGY TO METALS ("NICKEL ALLERGY"), DEPRESSION ("DEPRESSION") AND ANXIETY ("ANXIETY"). ON (B)(6) 2013, THE PATIENT EXPERIENCED HOT FLUSH ("HORMONAL CHANGES- HOT FLASHES"). ON (B)(6) 2013, THE PATIENT EXPERIENCED BLADDER DISORDER ("BLADDER PROBLEM") AND PREMATURE MENOPAUSE ("I FEEL LIKE I AM IN EARLY MENOPAUSE"). ON (B)(6) 2013, THE PATIENT UNDERWENT HAEMATOMA EVACUATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON (B)(6) 2013, THE PATIENT EXPERIENCED FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)") AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). ON (B)(6) 2014, THE PATIENT EXPERIENCED DENTAL CARIES ("TEETH DECAY") AND TOOTH LOSS ("TEETH FALLING OUT"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), BLADDER PERFORATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MENORRHAGIA ("MENORRHAGIA/ HEAVY BLEEDING"), URINARY TRACT DISORDER ("URINARY PROBLEM"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES"), COMPLICATION OF DEVICE REMOVAL ("COMPLICATION OF DEVICE REMOVAL") AND ABDOMINAL PAIN LOWER ("LOWER STOMACH PAIN- FELT LIKE I WAS IN LABOR PAIN"). THE PATIENT WAS TREATED WITH SURGERY (REMOVAL OF UTERUS AND RIGHT FALLOPIAN TUBE) AND SURGERY (LAPAROSCOPIC EVACUATION OF HEMATOMA ON (B)(6) 2013). ESSURE WAS REMOVED ON (B)(6) 2013. AT THE TIME OF THE REPORT, THE PELVIC PAIN, BLADDER PERFORATION, GENITAL HAEMORRHAGE, VAGINAL HAEMORRHAGE, MENORRHAGIA, RASH, URTICARIA, FEMALE SEXUAL DYSFUNCTION, BLADDER DISORDER, URINARY TRACT DISORDER, DENTAL CARIES, DYSPAREUNIA, FATIGUE, HOT FLUSH, WEIGHT INCREASED, MIGRAINE, HEADACHE, ALLERGY TO METALS AND DEPRESSION HAD NOT RESOLVED AND THE HAEMATOMA EVACUATION, ANXIETY, TOOTH LOSS, COMPLICATION OF DEVICE REMOVAL, ABDOMINAL PAIN LOWER AND PREMATURE MENOPAUSE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, ALLERGY TO METALS, ANXIETY, BLADDER DISORDER, BLADDER PERFORATION, COMPLICATION OF DEVICE REMOVAL, DENTAL CARIES, DEPRESSION, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GENITAL HAEMORRHAGE, HAEMATOMA EVACUATION, HEADACHE, HOT FLUSH, MENORRHAGIA, MIGRAINE, PELVIC PAIN, PREMATURE MENOPAUSE, RASH, TOOTH LOSS, URINARY TRACT DISORDER, URTICARIA, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE REPORTED HER SYMPTOMS, INCLUDING BLEEDING AND PAIN. THE PHYSICIAN WANTED TO DO A D+C; SINCE SHE WAS STILL HAVING PAIN WE DISCUSSED REMOVAL OF MY UTERUS. FIRST AMENDED PFS COMPLETED BY: SAMANTHA DINO 88 BEECH STREET MUSE, PA 01/11/1942 . 88 BEECH STREET MUSE, PA 01/09/1942. (DISCREPANCY BETWEEN TWO PFS NOTED). DATE(S) OF INSERTION: 22JUL2011 AND 20JUL2011(DISCREPANCY BETWEEN TWO PFS NOTED) DATE(S) . (DISCREPANCY BETWEEN TWO PFS NOTED) DATE: (B)(6) 2011 TYPE OF TEST: - DYE TEST RESULT: THEY WERE IN AND FINE. DATE OF RESULT: (B)(6) 2011 DATE: (B)(6) 2011 TYPE OF TEST: - DYE TEST RESULT: THEY WERE IN AND FINE. DATE OF RESULT: (B)(6) 2011 (DISCREPANCY BETWEEN TWO PFS NOTED) DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 40.6 KG/SQM. ON OCT-2011, DYE TEST RESULTED THEY WERE IN AND TUBES WERE OCCULATED DATE: (B)(6) 2011 TYPE OF TEST: - DYE TEST RESULT: THEY WERE IN AND FINE.DATE OF RESULT: (B)(6) 2011 DATE: (B)(6) 2011 TYPE OF TEST: - DYE TEST RESULT: THEY WERE IN AND FINE. DATE OF RESULT: (B)(6) 2011 (DISCREPANCY BETWEEN TWO PFS NOTED) QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 26-OCT-2018: PLAINTIFF FACT SHEET RECEIVED. INDICATION FEMALE STERILIZATION WAS ADDED. EVENTS: LOWER STOMACH PAIN- FELT LIKE I WAS IN LABOR PAIN, I FEEL LIKE I AM IN EARLY MENOPAUSE WERE NEWLY ADDED. 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 PELVIC PAIN ('PAIN/PAIN SEVERE AND PERSISTENT PAIN/LOWER STOMACH PAIN, FELT LIKE I WAS IN LABOR PAIN'), BLADDER PERFORATION ('PERFORATION (DOCTOR NICKED THE BLADDER WHEN REMOVING UTERUS), BLADDER INJURY DURING HEMATOMA EVACUATION SURGERY ON (B)(6) 2013') AND HAEMATOMA EVACUATION ('EVACUATION HEMATOMA'). IN A 26-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 841528), INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED GRAVIDA I, PARITY 1 ((B)(6) 2009), C-SECTION, FIBROMYALGIA, HERNIATED DISC, UTERINE DILATION AND CURETTAGE, NORMAL DELIVERY (LIVE CHILD). AND ANEMIA. ON (B)(6) 2011, DYE TEST RESULTED: THEY WERE IN AND TUBES WERE OCCULATED; DATE: (B)(6) 2011, TYPE OF TEST: DYE TEST RESULT: THEY WERE IN AND FINE. DATE OF RESULT: (B)(6)2011; DATE: (B)(6) 2011, TYPE OF TEST: DYE TEST RESULT: THEY WERE IN AND FINE. DATE OF RESULT: (B)(6) 2011. (DISCREPANCY BETWEEN TWO PFS NOTED). PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED, FOR AN UNREPORTED INDICATION: DEPO-PROVERA FROM (B)(6) 2010 TO (B)(6) 2013 AND BIRTH CONTROL PILLS FROM (B)(6) 2009 TO (B)(6)2010. CONCURRENT CONDITIONS INCLUDED: BODY MASS INDEX NORMAL, PENICILLIN ALLERGY, DYSMENORRHEA, PRURITUS, MENSES IRREGULAR, UTI, VAGINAL DRYNESS, DYSURIA AND PERITONEAL HEMATOMA. CONCOMITANT PRODUCTS INCLUDED: BUSPIRONE, ESCITALOPRAM OXALATE (LEXAPRO), NSAIDS, OXYCODONE HYDROCHLORIDE;PARACETAMOL (PERCOCET), PARACETAMOL (TYLENOL) AND PARACETAMOL + CAFFEINE + PYRILAMINE MALEATE (MIDOL COMPLETE FORMULA CAPLETS). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2011, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON (B)(6) 2011, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE ("HEAVY BLEEDING/ABNORMAL BLEEDING"), DERMATITIS ALLERGIC ("ALLERGIC/HYPERSENSITIVITY: RASHES") AND URTICARIA ("ALLERGIC/HYPERSENSITIVITY HIVES INSIDE OF MY THIGHS"). IN (B)(6) 2011, THE PATIENT EXPERIENCED ALLERGY TO METALS ("NICKEL ALLERGY"). IN (B)(6) 2011, THE PATIENT EXPERIENCED FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)") AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). IN (B)(6) 2011, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"). ON (B)(6)-2011, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE"), DEPRESSION ("DEPRESSION") AND ANXIETY ("ANXIETY"). AND WAS FOUND TO HAVE WEIGHT INCREASED ("HORMONAL CHANGES: WEIGHT GAIN"). IN (B)(6) 2012, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES") AND HEADACHE ("HEADACHES"). IN (B)(6) 2013, THE PATIENT EXPERIENCED HOT FLUSH ("HORMONAL CHANGES: HOT FLASHES"). IN (B)(6) 2013, THE PATIENT EXPERIENCED MENORRHAGIA ("MENORRHAGIA/HEAVY BLEEDING"). ON (B)(6) 2013, THE PATIENT UNDERWENT HAEMATOMA EVACUATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). AND EXPERIENCED BLADDER DISORDER ("BLADDER PROBLEM"), PREMATURE MENOPAUSE ("I FEEL LIKE I AM IN EARLY MENOPAUSE NOS") AND BLADDER INJURY ("BLADDER INJURY DURING HEMATOMA EVACUATION SURGERY ON"). ON (B)(6) 2014, THE PATIENT EXPERIENCED DENTAL CARIES ("DENTAL PROBLEMS: TEETH DECAY") AND TOOTH LOSS ("TEETH FALLING OUT/DENTAL PROBLEMS: FALLING OUT"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED BLADDER PERFORATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), URINARY TRACT DISORDER ("URINARY PROBLEM"), COMPLICATION OF DEVICE REMOVAL ("COMPLICATION OF DEVICE REMOVAL"), ABDOMINAL PAIN ("ABDOMEN PAIN"), DYSFUNCTIONAL UTERINE BLEEDING ("DYSFUNCTIONAL UTERINE BLEEDING") AND DYSMENORRHOEA ("DYSMENORRHEA"). THE PATIENT WAS TREATED WITH DULOXETINE HYDROCHLORIDE (CYMBALTA), IBUPROFEN, TRAZODONE, REMOVED TOP TEETH/PARTIAL DENTURES. AND SURGERY (LAPAROSCOPIC EVACUATION OF HEMATOMA ON (B)(6) 2013. AND TOTAL ABDOMINAL HYSTERECTOMY, RIGHT SALPINGECTOMY AND LEFT PARTIAL SALPINGECTOMY AND ESSURE REMOVAL). ESSURE WAS REMOVED ON (B)(6) 2013. AT THE TIME OF THE REPORT, THE PELVIC PAIN, BLADDER PERFORATION, GENITAL HAEMORRHAGE, MENORRHAGIA, DERMATITIS ALLERGIC, URTICARIA, FEMALE SEXUAL DYSFUNCTION, BLADDER DISORDER, URINARY TRACT DISORDER, DENTAL CARIES, DYSPAREUNIA, FATIGUE, HOT FLUSH, WEIGHT INCREASED, HEADACHE, ALLERGY TO METALS AND DEPRESSION HAD NOT RESOLVED. THE HAEMATOMA EVACUATION, ANXIETY, TOOTH LOSS, COMPLICATION OF DEVICE REMOVAL, PREMATURE MENOPAUSE, BLADDER INJURY, ABDOMINAL PAIN, DYSFUNCTIONAL UTERINE BLEEDING AND DYSMENORRHOEA OUTCOME WAS UNKNOWN. THE VAGINAL HAEMORRHAGE HAD RESOLVED. AND THE MIGRAINE WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALLERGY TO METALS, ANXIETY, BLADDER DISORDER, BLADDER INJURY, BLADDER PERFORATION, COMPLICATION OF DEVICE REMOVAL, DENTAL CARIES, DEPRESSION, DERMATITIS ALLERGIC, DYSFUNCTIONAL UTERINE BLEEDING, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GENITAL HAEMORRHAGE, HAEMATOMA EVACUATION, HEADACHE, HOT FLUSH, MENORRHAGIA, MIGRAINE, PELVIC PAIN, PREMATURE MENOPAUSE, TOOTH LOSS, URINARY TRACT DISORDER, URTICARIA, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE REPORTED HER SYMPTOMS, INCLUDING BLEEDING AND PAIN. THE PHYSICIAN WANTED TO DO A D+C. SINCE SHE WAS STILL HAVING PAIN, THEY DISCUSSED REMOVAL OF HER UTERUS. STATUS POST: TOTAL ABDOMINAL HYSTERECTOMY WITH RIGHT SALPINGECTOMY ON (B)(6) 2013. THE PATIENT WAS FOUND TO DEVELOP AN INTRAPERITONEAL BLEED AND WAS TAKEN TO THE OPERATING ROOM AGAIN ON (B)(6) 2013 FOR EXPLORATORY LAPAROTOMY, EVACUATION OF HEMATOMA, AND SUTURING OF BLEEDERS. (DISCREPANCY BETWEEN TWO PFS NOTED): DATE(S) OF INSERTION: (B)(6) 2011, (DISCREPANCY BETWEEN TWO PFS NOTED); DATE(S) (DISCREPANCY BETWEEN TWO PFS NOTED): DATE: (B)(6) 2011, TYPE OF TEST: DYE TEST RESULT: THEY WERE IN AND FINE. DATE OF RESULT: (B)(6) 2011. DATE: (B)(6) 2011, TYPE OF TEST: DYE TEST RESULT: THEY WERE IN AND FINE. DATE OF RESULT: (B)(6) 2011. (DISCREPANCY BETWEEN TWO PFS NOTED). DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS: INDEX WAS 19 KG/SQM. HYSTEROSALPINGOGRAM: ON (B)(6) 2011, TOTAL BILATERAL OCCLUSION. COMPLETE OCCLUSION OF THE FALLOPIAN TUBES BY THE ESSURE WIRES. PREGNANCY TEST: ON AN UNKNOWN DATE, NEGATIVE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS: MENORRHAGIA, PELVIC PAIN. QUALITY SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2020, MEDICAL RECORDS RECEIVED: EVENTS ADDED FROM MR: DYSFUNCTIONAL UTERINE BLEEDING, DYSMENORRHEA. MEDICAL HISTORY WERE ADDED. A TECHNICAL INVESTIGATION WAS 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.
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN"), BLADDER PERFORATION ("PERFORATION (DOCTOR NICKED THE BLADDER WHEN REMOVING UTERUS)"), GENITAL HAEMORRHAGE ("HEAVY BLEEDING") AND HAEMATOMA EVACUATION ("EVACUATION HEMATOMA") IN A 28-YEAR-OLD PATIENT WHO HAD ESSURE (BATCH NO. 841528) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED GRAVIDA I, PARITY 1 (B)(6) 2009), C-SECTION, FIBROMYALGIA AND HERNIATED DISC. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: DEPO-PROVERA FROM MARCH 2010 TO SEPTEMBER 2013 AND BIRTH CONTROL PILLS FROM NOVEMBER 2009 TO MARCH 2010. CONCURRENT CONDITIONS INCLUDED MORBID OBESITY AND PENICILLIN ALLERGY. CONCOMITANT PRODUCTS INCLUDED BUSPIRONE, ESCITALOPRAM OXALATE (LEXAPRO) AND OXYCOCET (PERCOCET). IN (B)(6) 2011, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN AUGUST 2011, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGNIAL)"), RASH ("RASHES"), URTICARIA ("HIVES INSIDE OF MY THIGHS") AND ALLERGY TO METALS ("NICKEL ALLERGY"). IN (B)(6) 2011, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE"), WEIGHT INCREASED ("WEIGHT GAIN"), DEPRESSION ("DEPRESSION") AND ANXIETY ("ANXIETY"). ON (B)(6) 2013, 2 YEARS 1 MONTH AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED BLADDER DISORDER ("BLADDER PROBLEM"), DENTAL CARIES ("TEETH DECAY"), HOT FLUSH ("HOT FLASHES") AND TOOTH LOSS ("TEETH FALLING OUT"). ON (B)(6) 2013, THE PATIENT UNDERWENT HAEMATOMA EVACUATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). IN (B)(6) 2013, THE PATIENT EXPERIENCED FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)") AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED BLADDER PERFORATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MENORRHAGIA ("MENORRHAGIA"), URINARY TRACT DISORDER ("URINARY PROBLEM"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES") AND COMPLICATION OF DEVICE REMOVAL ("COMPLICATION OF DEVICE REMOVAL"). THE PATIENT WAS TREATED WITH SURGERY (REMOVAL OF UTERUS AND RIGHT FALLOPIAN TUBE) AND SURGERY (LAPAROSCOPIC EVACUATION OF HEMATOMA ON (B)(6) 2013). ESSURE WAS REMOVED ON (B)(6) 2013. AT THE TIME OF THE REPORT, THE PELVIC PAIN, BLADDER PERFORATION, GENITAL HAEMORRHAGE, VAGINAL HAEMORRHAGE, MENORRHAGIA, RASH, URTICARIA, FEMALE SEXUAL DYSFUNCTION, BLADDER DISORDER, URINARY TRACT DISORDER, DENTAL CARIES, DYSPAREUNIA, FATIGUE, HOT FLUSH, WEIGHT INCREASED, MIGRAINE, HEADACHE, ALLERGY TO METALS AND DEPRESSION HAD NOT RESOLVED AND THE HAEMATOMA EVACUATION, ANXIETY, TOOTH LOSS AND COMPLICATION OF DEVICE REMOVAL OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ALLERGY TO METALS, ANXIETY, BLADDER DISORDER, BLADDER PERFORATION, COMPLICATION OF DEVICE REMOVAL, DENTAL CARIES, DEPRESSION, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GENITAL HAEMORRHAGE, HAEMATOMA EVACUATION, HEADACHE, HOT FLUSH, MENORRHAGIA, MIGRAINE, PELVIC PAIN, RASH, TOOTH LOSS, URINARY TRACT DISORDER, URTICARIA, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE REPORTED HER SYMPTOMS, INCLUDING BLEEDING AND PAIN. THE PHYSICIAN WANTED TO DO A D+C; SINCE SHE WAS STILL HAVING PAIN WE DISCUSSED REMOVAL OF MY UTERUS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 40.6 KG/SQM. ON (B)(6) 2011, DYE TEST RESULTED THEY WERE IN AND TUBES WERE OCCULATED QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 22-AUG-2018: QUALITY-SAFETY EVALUATION OF PTC 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 PELVIC PAIN ("PAIN / PAIN SEVERE AND PERSISTENT PAIN / LOWER STOMACH PAIN- FELT LIKE I WAS IN LABOR PAIN"), BLADDER PERFORATION ("PERFORATION (DOCTOR NICKED THE BLADDER WHEN REMOVING UTERUS) / BLADDER INJURY DURING HEMATOMA EVACUATION SURGERY ON (B)(6) 2013"), GENITAL HAEMORRHAGE ("HEAVY BLEEDING/ ABNORMAL BLEEDING") AND HAEMATOMA EVACUATION ("EVACUATION HEMATOMA") IN A 26-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 841528) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED GRAVIDA I, PARITY 1 ((B)(6) 2009), C-SECTION, FIBROMYALGIA, HERNIATED DISC, UTERINE DILATION AND CURETTAGE AND NORMAL DELIVERY (LIVE CHILD). * ON (B)(6) 2011, DYE TEST RESULTED THEY WERE IN AND TUBES WERE OCCULATED DATE: (B)(6) 2011 TYPE OF TEST: - DYE TEST RESULT: THEY WERE IN AND FINE.DATE OF RESULT: (B)(6) 2011 DATE: (B)(6) 2011 TYPE OF TEST: - DYE TEST RESULT: THEY WERE IN AND FINE. DATE OF RESULT: (B)(6) 2011 (DISCREPANCY BETWEEN TWO PFS NOTED). PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: DEPO-PROVERA FROM (B)(6) 2010 TO (B)(6) 2013 AND BIRTH CONTROL PILLS FROM (B)(6) 2009 TO (B)(6) 2010. CONCURRENT CONDITIONS INCLUDED BODY MASS INDEX NORMAL, PENICILLIN ALLERGY, DYSMENORRHEA, PRURITUS, MENSES IRREGULAR, UTI, VAGINAL DRYNESS, DYSURIA AND PERITONEAL HEMATOMA. CONCOMITANT PRODUCTS INCLUDED BUSPIRONE, ESCITALOPRAM OXALATE (LEXAPRO), NSAIDS, OXYCODONE HYDROCHLORIDE;PARACETAMOL (PERCOCET), PARACETAMOL (TYLENOL) AND PARACETAMOL + CAFFEINE + PYRILAMINE MALEATE (MIDOL COMPLETE FORMULA CAPLETS). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2011, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON (B)(6) 2011, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DERMATITIS ALLERGIC ("ALLERGIC/HYPERSENSITIVITY: RASHES") AND URTICARIA ("ALLERGIC/HYPERSENSITIVITY HIVES INSIDE OF MY THIGHS"). IN (B)(6) 2011, THE PATIENT EXPERIENCED ALLERGY TO METALS ("NICKEL ALLERGY"). IN (B)(6) 2011, THE PATIENT EXPERIENCED FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)") AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). IN (B)(6) 2011, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGNIAL)"). ON (B)(6) 2011, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE"), DEPRESSION ("DEPRESSION") AND ANXIETY ("ANXIETY") AND WAS FOUND TO HAVE WEIGHT INCREASED ("HORMONAL CHANGES: WEIGHT GAIN"). IN (B)(6) 2012, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES") AND HEADACHE ("HEADACHES"). IN (B)(6) 2013, THE PATIENT EXPERIENCED HOT FLUSH ("HORMONAL CHANGES- HOT FLASHES"). IN (B)(6) 2013, THE PATIENT EXPERIENCED MENORRHAGIA ("MENORRHAGIA/ HEAVY BLEEDING"). ON (B)(6) 2013, THE PATIENT UNDERWENT HAEMATOMA EVACUATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND EXPERIENCED BLADDER DISORDER ("BLADDER PROBLEM"), PREMATURE MENOPAUSE ("I FEEL LIKE I AM IN EARLY MENOPAUSE NOS") AND URINARY TRACT PROCEDURAL COMPLICATION ("BLADDER INJURY DURING HEMATOMA EVACUATION SURGERY ON"). ON (B)(6) 2014, THE PATIENT EXPERIENCED DENTAL CARIES ("DENTAL PROBLEMS : TEETH DECAY") AND TOOTH LOSS ("TEETH FALLING OUT / DENTAL PROBLEMS FALLING OUT"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED BLADDER PERFORATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), URINARY TRACT DISORDER ("URINARY PROBLEM"), COMPLICATION OF DEVICE REMOVAL ("COMPLICATION OF DEVICE REMOVAL") AND ABDOMINAL PAIN ("ABDOMEN PAIN"). THE PATIENT WAS TREATED WITH DULOXETINE HYDROCHLORIDE (CYMBALTA), IBUPROFEN, TRAZODONE, REMOVED TOP TEETH / PARTIAL DENTURES AND SURGERY (LAPAROSCOPIC EVACUATION OF HEMATOMA ON (B)(6) 2013 AND TOTAL ABDOMINAL HYSTERECTOMY, RIGHT SALPINGECTOMY AND LEFT PARTIAL SALPINGECTOMY AND ESSURE REMOVAL). ESSURE WAS REMOVED ON (B)(6) 2013. AT THE TIME OF THE REPORT, THE PELVIC PAIN, BLADDER PERFORATION, GENITAL HAEMORRHAGE, MENORRHAGIA, DERMATITIS ALLERGIC, URTICARIA, FEMALE SEXUAL DYSFUNCTION, BLADDER DISORDER, URINARY TRACT DISORDER, DENTAL CARIES, DYSPAREUNIA, FATIGUE, HOT FLUSH, WEIGHT INCREASED, HEADACHE, ALLERGY TO METALS AND DEPRESSION HAD NOT RESOLVED, THE HAEMATOMA EVACUATION, ANXIETY, TOOTH LOSS, COMPLICATION OF DEVICE REMOVAL, PREMATURE MENOPAUSE, URINARY TRACT PROCEDURAL COMPLICATION AND ABDOMINAL PAIN OUTCOME WAS UNKNOWN, THE VAGINAL HAEMORRHAGE HAD RESOLVED AND THE MIGRAINE WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALLERGY TO METALS, ANXIETY, BLADDER DISORDER, BLADDER PERFORATION, COMPLICATION OF DEVICE REMOVAL, DENTAL CARIES, DEPRESSION, DERMATITIS ALLERGIC, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GENITAL HAEMORRHAGE, HAEMATOMA EVACUATION, HEADACHE, HOT FLUSH, MENORRHAGIA, MIGRAINE, PELVIC PAIN, PREMATURE MENOPAUSE, TOOTH LOSS, URINARY TRACT DISORDER, URINARY TRACT PROCEDURAL COMPLICATION, URTICARIA, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE REPORTED HER SYMPTOMS, INCLUDING BLEEDING AND PAIN. THE PHYSICIAN WANTED TO DO A D+C; SINCE SHE WAS STILL HAVING PAIN THEY DISCUSSED REMOVAL OF HER UTERUS. STATUS POST TOTAL ABDOMINAL HYSTERECTOMY WITH RIGHT SALPINGECTOMY ON (B)(6) 2013: THE PATIENT WAS FOUND TO DEVELOP AN INTRAPERITONEAL BLEED AND WAS TAKEN TO THE OPERATING ROOM AGAIN ON (B)(6) 2013 FOR EXPLORATORY LAPAROTOMY, EVACUATION OF HEMATOMA, AND SUTURING OF BLEEDERS. (DISCREPANCY BETWEEN TWO PFS NOTED) DATE(S) OF INSERTION: (B)(6) 2011 AND (B)(6) 2011 (DISCREPANCY BETWEEN TWO PFS NOTED) DATE(S) (DISCREPANCY BETWEEN TWO PFS NOTED) DATE: (B)(6) 2011 TYPE OF TEST: - DYE TEST RESULT: THEY WERE IN AND FINE. DATE OF RESULT: (B)(6) 2011 DATE: (B)(6) 2011 TYPE OF TEST: - DYE TEST RESULT: THEY WERE IN AND FINE. DATE OF RESULT: (B)(6) 2011 (DISCREPANCY BETWEEN TWO PFS NOTED) DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 19 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2011: TOTAL BILATERAL OCCLUSION. COMPLETE OCCLUSION OF THE FALLOPIAN TUBES BY THE ESSURE WIRES.. PREGNANCY TEST - ON AN UNKNOWN DATE: NEGATIVE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS: MENORRHAGIA, PELVIC PAIN. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 2-MAY-2019: PFS AND MR RECEIVED: EVENTS: BLADDER INJURY AND ABDOMINAL PAIN WERE ADDED. EVENT ONSET DATE WERE UPDATED. EVENT SEVERITY WERE ADDED. EVENT OF "LOWER STOMACH PAIN- FELT LIKE I WAS IN LABOR PAIN" CLUBBED WITH "PELVIC PAIN". EVENT OUTCOME OF MIGRAINE AND VAGINAL HEMORRHAGE WERE UPDATED. MEDICAL HISTORY AND CONCOMITANT CONDITIONS WERE ADDED. LAB DATA WERE ADDED. REPORTER CAUSALITY COMMENTS WERE ADDED. INCIDENT 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN"), BLADDER PERFORATION ("PERFORATION (DOCTOR NICKED THE BLADDER WHEN REMOVING UTERUS)"), GENITAL HAEMORRHAGE ("HEAVY BLEEDING") AND HAEMATOMA ("EVACUATION HEMATOMA") IN A (B)(6)-YEAR-OLD PATIENT WHO HAD ESSURE (BATCH NO. 841528) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED GRAVIDA I, PARITY 1 (B)(6) (2009), C-SECTION, FIBROMYALGIA AND HERNIATED DISC. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: DEPO-PROVERA FROM (B)(6) 2010 TO (B)(6) 2013 AND BIRTH CONTROL PILLS FROM (B)(6) 2009 TO (B)(6) 2010. CONCURRENT CONDITIONS INCLUDED OVERWEIGHT AND PENICILLIN ALLERGY. CONCOMITANT PRODUCTS INCLUDED BUSPIRONE, ESCITALOPRAM OXALATE (LEXAPRO) AND OXYCOCET (PERCOCET). IN (B)(6) 2011, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), RASH ("RASHES"), URTICARIA ("HIVES INSIDE OF MY THIGHS") AND ALLERGY TO METALS ("NICKEL ALLERGY"). IN (B)(6) 2011, THE PATIENT EXPERIENCED FATIGUE ("FATIGUE"), WEIGHT INCREASED ("WEIGHT GAIN"), DEPRESSION ("DEPRESSION") AND ANXIETY ("ANXIETY"). ON (B)(6) 2013, 2 YEARS 1 MONTH AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED BLADDER DISORDER ("BLADDER PROBLEM"), DENTAL CARIES ("TEETH DECAY"), HOT FLUSH ("HOT FLASHES") AND TOOTH LOSS ("TEETH FALLING OUT"). ON (B)(6) 2013, THE PATIENT EXPERIENCED HAEMATOMA (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). IN (B)(6) 2013, THE PATIENT EXPERIENCED FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)") AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED BLADDER PERFORATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), MENORRHAGIA ("MENORRHAGIA"), URINARY TRACT DISORDER ("URINARY PROBLEM"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES") AND COMPLICATION OF DEVICE REMOVAL ("COMPLICATION OF DEVICE REMOVAL"). THE PATIENT WAS TREATED WITH SURGERY (REMOVAL OF UTERUS AND RIGHT FALLOPIAN TUBE) AND SURGERY (LAPAROSCOPIC EVACUATION OF HEMATOMA ON (B)(6) 2013). ESSURE WAS REMOVED ON (B)(6) 2013. AT THE TIME OF THE REPORT, THE PELVIC PAIN, BLADDER PERFORATION, GENITAL HAEMORRHAGE, VAGINAL HAEMORRHAGE, MENORRHAGIA, RASH, URTICARIA, FEMALE SEXUAL DYSFUNCTION, BLADDER DISORDER, URINARY TRACT DISORDER, DENTAL CARIES, DYSPAREUNIA, FATIGUE, HOT FLUSH, WEIGHT INCREASED, MIGRAINE, HEADACHE, ALLERGY TO METALS AND DEPRESSION HAD NOT RESOLVED AND THE HAEMATOMA, ANXIETY, TOOTH LOSS AND COMPLICATION OF DEVICE REMOVAL OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ALLERGY TO METALS, ANXIETY, BLADDER DISORDER, BLADDER PERFORATION, COMPLICATION OF DEVICE REMOVAL, DENTAL CARIES, DEPRESSION, DYSPAREUNIA, FATIGUE, FEMALE SEXUAL DYSFUNCTION, GENITAL HAEMORRHAGE, HAEMATOMA, HEADACHE, HOT FLUSH, MENORRHAGIA, MIGRAINE, PELVIC PAIN, RASH, TOOTH LOSS, URINARY TRACT DISORDER, URTICARIA, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE REPORTED HER SYMPTOMS, INCLUDING BLEEDING AND PAIN. THE PHYSICIAN WANTED TO DO A D+C; SINCE SHE WAS STILL HAVING PAIN WE DISCUSSED REMOVAL OF MY UTERUS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 40.6 KG/SQM. ON (B)(6) 2011, DYE TEST RESULTED THEY WERE IN AND TUBES WERE OCCULTED MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 27-FEB-2018: PLAINTIFF FACT SHEET WAS RECEIVED- ALL RELEVANT MEDICAL HISTORY, CONCURRENT CONDITION, CONCOMITANT MEDICATION, LOT NUMBER WERE ADDED. EVENTS PELVIC PAIN, BLADDER PERFORATION, GENITAL HAEMORRHAGE, VAGINAL HAEMORRHAGE, MENORRHAGIA, RASH, URTICARIA, FEMALE SEXUAL DYSFUNCTION, BLADDER DISORDER, URINARY TRACT DISORDER, DENTAL CARIES, DYSPAREUNIA, FATIGUE, HOT FLUSH, WEIGHT INCREASED, MIGRAINE, HEADACHE, ALLERGY TO METALS, DEPRESSION, ANXIETY, TOOTH LOSS, HAEMATOMA EVACUATION. 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 229890 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 841528 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 26 YR | Other| R | BUSPIRONE| BUSPIRONE| BUSPIRONE| BUSPIRONE| BUSPIRONE| BUSPIRONE| LEXAPRO| LEXAPRO| LEXAPRO| LEXAPRO| LEXAPRO| LEXAPRO| MIDOL COMPLETE FORMULA CAPLETS| MIDOL COMPLETE FORMULA CAPLETS| MIDOL COMPLETE FORMULA CAPLETS| NSAIDS| NSAIDS| NSAIDS| PERCOCET| PERCOCET| PERCOCET| PERCOCET [OXYCODONE HYDROCHLORIDE,PARACETAMOL]| PERCOCET [OXYCODONE HYDROCHLORIDE,PARACETAMOL]| PERCOCET [OXYCODONE HYDROCHLORIDE,PARACETAMOL]| TYLENOL| TYLENOL| TYLENOL [PARACETAMOL]| BUSPIRONE| LEXAPRO| PERCOCET |