ESSURE
Report
- Report Number
- 2951250-2019-09457
- Event Type
- Injury
- Date Received
- October 4, 2019
- Report Date
- February 2, 2021
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- 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 PELVIC PAIN ('PELVIC PAIN / CHRONIC') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 952109) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2014, HE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN ("ABDOMINAL PAIN"), BACK PAIN ("BACK PAIN"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), MENORRHAGIA ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)"), VAGINAL INFECTION ("BLADDER/URINARY PROBLEMS: VAGINAL. INFECTION"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), FATIGUE ("FATIGUE"), ALOPECIA ("HAIR LOSS"), GASTROINTESTINAL DISORDER ("GASTROINTESTINAL DISORDER"), NERVOUS SYSTEM DISORDER ("NEURO CONDITION /PROBLEMS"), MIGRAINE ("MIGRAINE"), ABDOMINAL DISTENSION ("BLOATING") AND MEMORY IMPAIRMENT ("FORGETFULNESS"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY. (FULL),SALPINGECTOMY. (BILATERAL)). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ABDOMINAL PAIN, BACK PAIN, DYSMENORRHOEA, VAGINAL INFECTION, VAGINAL DISCHARGE, FATIGUE, ALOPECIA, GASTROINTESTINAL DISORDER, NERVOUS SYSTEM DISORDER, MIGRAINE, ABDOMINAL DISTENSION AND MEMORY IMPAIRMENT OUTCOME WAS UNKNOWN AND THE MENORRHAGIA HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ALOPECIA, BACK PAIN, DYSMENORRHOEA, FATIGUE, GASTROINTESTINAL DISORDER, MEMORY IMPAIRMENT, MENORRHAGIA, MIGRAINE, NERVOUS SYSTEM DISORDER, PELVIC PAIN, VAGINAL DISCHARGE AND VAGINAL INFECTION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: REMOVAL DATE: (B)(6) 2013 (DISCREPANCY NOTED AS PER MR). INSERTION DATE: (B)(6) 2012 DISCRIPANCY NOTED. TRAILING COILS: LEFT 1 RIGHT 4. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 26-JAN-2021: MR RECEIVED: LOT NUMBER, REPORTER, AND RCC NOTE WERE ADDED. WE RECEIVED A LOT NUMBER IN THIS CASE. 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN / CHRONIC') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 952109) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN ("ABDOMINAL PAIN"), BACK PAIN ("BACK PAIN"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), MENORRHAGIA ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)"), VAGINAL INFECTION ("BLADDER/URINARY PROBLEMS: VAGINAL. INFECTION"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), FATIGUE ("FATIGUE"), ALOPECIA ("HAIR LOSS"), GASTROINTESTINAL DISORDER ("GASTROINTESTINAL DISORDER"), NERVOUS SYSTEM DISORDER ("NEURO CONDITION /PROBLEMS"), MIGRAINE ("MIGRAINE"), ABDOMINAL DISTENSION ("BLOATING") AND MEMORY IMPAIRMENT ("FORGETFULNESS"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY. (FULL),SALPINGECTOMY. (BILATERAL)). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ABDOMINAL PAIN, BACK PAIN, DYSMENORRHOEA, VAGINAL INFECTION, VAGINAL DISCHARGE, FATIGUE, ALOPECIA, GASTROINTESTINAL DISORDER, NERVOUS SYSTEM DISORDER, MIGRAINE, ABDOMINAL DISTENSION AND MEMORY IMPAIRMENT OUTCOME WAS UNKNOWN AND THE MENORRHAGIA HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ALOPECIA, BACK PAIN, DYSMENORRHOEA, FATIGUE, GASTROINTESTINAL DISORDER, MEMORY IMPAIRMENT, MENORRHAGIA, MIGRAINE, NERVOUS SYSTEM DISORDER, PELVIC PAIN, VAGINAL DISCHARGE AND VAGINAL INFECTION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: REMOVAL DATE: (B)(6) 2013 (DISCREPANCY NOTED AS PER MR). INSERTION DATE: (B)(6) 2012. DISCREPANCY NOTED. TRAILING COILS: LEFT 1 RIGHT 4. LOT NUMBER: 952109; MANUFACTURING DATE: 2012-02; EXPIRATION DATE: 2015-02. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 3-FEB-2021: QUALITY SAFETY EVALUATION OF PTC. WE RECEIVED A LOT NUMBER IN THIS CASE. 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN / CHRONIC') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN ("ABDOMINAL PAIN"), BACK PAIN ("BACK PAIN"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), MENORRHAGIA ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)"), VAGINAL INFECTION ("BLADDER/URINARY PROBLEMS: VAGINAL. INFECTION"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), FATIGUE ("FATIGUE"), ALOPECIA ("HAIR LOSS"), GASTROINTESTINAL DISORDER ("GASTROINTESTINAL DISORDER"), NERVOUS SYSTEM DISORDER ("NEURO CONDITION /PROBLEMS"), MIGRAINE ("MIGRAINE"), ABDOMINAL DISTENSION ("BLOATING") AND MEMORY IMPAIRMENT ("FORGETFULNESS"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY. (FULL),SALPINGECTOMY. (BILATERAL)). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ABDOMINAL PAIN, BACK PAIN, DYSMENORRHOEA, VAGINAL INFECTION, VAGINAL DISCHARGE, FATIGUE, ALOPECIA, GASTROINTESTINAL DISORDER, NERVOUS SYSTEM DISORDER, MIGRAINE, ABDOMINAL DISTENSION AND MEMORY IMPAIRMENT OUTCOME WAS UNKNOWN AND THE MENORRHAGIA HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ALOPECIA, BACK PAIN, DYSMENORRHOEA, FATIGUE, GASTROINTESTINAL DISORDER, MEMORY IMPAIRMENT, MENORRHAGIA, MIGRAINE, NERVOUS SYSTEM DISORDER, PELVIC PAIN, VAGINAL DISCHARGE AND VAGINAL INFECTION TO BE RELATED TO ESSURE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 13-SEP-2019: PFS RECEIVED. PREVIOUSLY REPORTED EVENT "INJURY" WAS UPDATED TO PELVIC PAIN. EVENTS; CHRONIC, ABDOMINAL, BACK, DYSMENORRHEA (CRAMPING), BLEEDING: MENORRHAGIA (HEAVY MENSTRUAL BLEEDING), BLADDER/URINARY PROBLEMS: VAGINAL. INFECTION. VAGINAL. DISCHARGE, FATIGUE, HAIR LOSS, GI CONDITIONS, NEURO CONDITION/PROBLEMS, MIGRAINE, BLOATING, FORGETFULNESS WERE ADDED. 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 951151 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 952109 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R |