ESSURE
Report
- Report Number
- 2951250-2019-05526
- Event Type
- Injury
- Date Received
- September 6, 2019
- Report Date
- February 9, 2021
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ('MIGRATION') AND MENORRHAGIA ('MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 872990) 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 "PATIENT DID NOT UNDERGO ESSURE CONFIRMATION TEST". THE PATIENT'S MEDICAL HISTORY INCLUDED UTI, VAGINAL BLEEDING, BLEEDING GENITAL, HEAVY PERIODS, UTERINE LEIOMYOMA, BURSITIS, ENDOMETRIOSIS, PELVIC PAIN FEMALE, BASAL CELL CARCINOMA, OSTEOARTHRITIS, IRON DEFICIENCY ANEMIA, UTERINE FIBROID, MENORRHAGIA, ADENOMYOSIS, UTERINE FIBROID, VAGINAL PROLAPSE, CYSTOSCOPY, OVARIAN CYST AND CYSTOSCOPY. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: OXYCODONE, IBUPROFEN, CHOLECALCIFEROL, ZANTAC, OMEGA-3, PROPRANOLOL, TYLENOL AND LEXAPRO. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), METRORRHAGIA ("METRORRHAGIA (BLEEDING BETWEEN PERIODS)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), VAGINAL INFECTION ("VAGINAL INFECTION"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE") AND FATIGUE ("FATIGUE"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL ON (B)(6) 2017, HYSTERECTOMY (PARTIAL) AND ENDOMETRIAL ABLATION ON (B)(6) 2012). ESSURE WAS REMOVED ON (B)(6) 2012. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, MENORRHAGIA, METRORRHAGIA, DYSPAREUNIA, VAGINAL INFECTION, VAGINAL DISCHARGE AND FATIGUE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DEVICE DISLOCATION, DYSPAREUNIA, FATIGUE, MENORRHAGIA, METRORRHAGIA, VAGINAL DISCHARGE AND VAGINAL INFECTION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED IN DATE OF INSERTION (B)(6) 2011 AND DATE OF REMOVAL (B)(6) 2017. THE NUMBER OF EXPANDED COILS THAT APPEARED TRAILING INTO THE UTERINE CAVITY WAS 9, ON OPPOSITE SITE THE NUMBER OF EXPANDED COILS THAT APPEARED TRAILING INTO THE UTERINE CAVITY WAS 2. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2021: MR RECEIVED: PREVIOUSLY REPORTED EVENT 'MENORRHAGIA' WAS MADE MEDICAL SIGNIFICANT AND INTERVENTION REQUIRED DUE TO ADDED SURGERY. LOT NUMBER, MEDICAL HISTORY, REPORTER INFORMATION 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 DEVICE DISLOCATION ('MIGRATION') AND MENORRHAGIA ('MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)'). IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 872990), 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, "PATIENT DID NOT UNDERGO ESSURE CONFIRMATION TEST". THE PATIENT'S MEDICAL HISTORY INCLUDED: UTI, VAGINAL BLEEDING, BLEEDING GENITAL, HEAVY PERIODS, UTERINE LEIOMYOMA, BURSITIS, ENDOMETRIOSIS, PELVIC PAIN FEMALE, BASAL CELL CARCINOMA, OSTEOARTHRITIS, IRON DEFICIENCY ANEMIA, UTERINE FIBROID, MENORRHAGIA, ADENOMYOSIS, UTERINE FIBROID, VAGINAL PROLAPSE, CYSTOSCOPY, OVARIAN CYST AND CYSTOSCOPY. PREVIOUSLY ADMINISTERED PRODUCTS, INCLUDED FOR AN UNREPORTED INDICATION: OXYCODONE, IBUPROFEN, CHOLECALCIFEROL, ZANTAC, OMEGA-3, PROPRANOLOL, TYLENOL AND LEXAPRO. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), METRORRHAGIA ("METRORRHAGIA (BLEEDING BETWEEN PERIODS)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), VAGINAL INFECTION ("VAGINAL INFECTION"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE") AND FATIGUE ("FATIGUE"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL ON (B)(6) 2017, HYSTERECTOMY (PARTIAL) AND ENDOMETRIAL ABLATION ON (B)(6) 2012). ESSURE WAS REMOVED ON (B)(6) 2012. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, MENORRHAGIA, METRORRHAGIA, DYSPAREUNIA, VAGINAL INFECTION, VAGINAL DISCHARGE AND FATIGUE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DEVICE DISLOCATION, DYSPAREUNIA, FATIGUE, MENORRHAGIA, METRORRHAGIA, VAGINAL DISCHARGE AND VAGINAL INFECTION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED, IN DATE OF INSERTION (B)(6) 2011. AND DATE OF REMOVAL (B)(6) 2017. THE NUMBER OF EXPANDED COILS THAT APPEARED TRAILING INTO THE UTERINE CAVITY WAS 9. ON OPPOSITE SITE THE NUMBER OF EXPANDED COILS THAT APPEARED TRAILING INTO THE UTERINE CAVITY WAS 2. LOT NUMBER#: 872990, MANUFACTURE DATE: 2011-06, EXPIRATION DATE: 2014-06. QUALITY SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 9-FEB-2021, QUALITY SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. 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 DEVICE DISLOCATION ('MIGRATION') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE 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 "PATIENT DID NOT UNDERGO ESSURE CONFIRMATION TEST". ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), METRORRHAGIA ("METRORRHAGIA (BLEEDING BETWEEN PERIODS)"), MENORRHAGIA ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), VAGINAL INFECTION ("VAGINAL INFECTION"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE") AND FATIGUE ("FATIGUE"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL ON (B)(6) 2017, HYSTERECTOMY (PARTIAL)). ESSURE WAS REMOVED ON (B)(6) 2012. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, METRORRHAGIA, MENORRHAGIA, DYSPAREUNIA, VAGINAL INFECTION, VAGINAL DISCHARGE AND FATIGUE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DEVICE DISLOCATION, DYSPAREUNIA, FATIGUE, MENORRHAGIA, METRORRHAGIA, 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 30-AUG-2019: PFS RECEIVED- PREVIOUSLY REPORTED EVENT "INJURY" WAS UPDATED TO EVENT MIGRATION, DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), METRORRHAGIA (BLEEDING BETWEEN PERIODS), MENORRHAGIA (HEAVY MENSTRUAL BLEEDING),VAGINAL INFECTION, VAGINAL DISCHARGE, FATIGUE AND PATIENT DID NOT UNDERGO ESSURE CONFIRMATION TEST. 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 763778 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 872990 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R |