ESSURE
Report
- Report Number
- 2951250-2019-08950
- Event Type
- Injury
- Date Received
- September 30, 2019
- Report Date
- April 25, 2021
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF FALLOPIAN TUBE PERFORATION ('PERFORATION: FALLOPIAN TUBES / MIGRATION') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 882184) 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 UNDERWENT ESSURE CONFIRMATION TEST". ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), PELVIC PAIN ("PELVIC PAIN "), ABDOMINAL PAIN ("ABDOMINAL PAIN"), MENORRHAGIA ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)"), URINARY TRACT INFECTION ("URINARY TRACT INFECTION") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE") AND WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("HORMONAL IMBALANCE") AND WEIGHT INCREASED ("WEIGHT GAIN"). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, DYSMENORRHOEA, PELVIC PAIN, ABDOMINAL PAIN, MENORRHAGIA, URINARY TRACT INFECTION, VAGINAL DISCHARGE, HORMONE LEVEL ABNORMAL AND WEIGHT INCREASED OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, DYSMENORRHOEA, FALLOPIAN TUBE PERFORATION, HORMONE LEVEL ABNORMAL, MENORRHAGIA, PELVIC PAIN, URINARY TRACT INFECTION, VAGINAL DISCHARGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT RECEIVED TREATMENT FOR PAIN, URINARY TRACT INFECTION, VAGINAL DISCHARGE INSERTION DATE PROVIDED IN MR : (B)(6) 2011(DISCREPANCY NOTED). LOT NUMBER: 882184 MANUFACTURE DATE: 2011-07 EXPIRATION DATE: 2014-07. QUALITY-SAFETY EVALUATION OF PTC: NO DEFECT COULD BE CONFIRMED BY THE MANUFACTURER. ALL COMPONENT BATCHES USED FOR MANUFACTURING OF THIS PRODUCT BATCH FULFILLED THE SET SPECIFICATIONS. BATCH DOCUMENTATION DID NOT REVEAL ANY DEVIATIONS DURING THE MANUFACTURING PROCESS THAT COULD HAVE CAUSED THE DESCRIBED COMPLAINT REASON. TREND ANALYSES OF COMPLAINTS ARE REVIEWED REGULARLY, NO SIGNAL WAS OBSERVED WITH REGARD TO THE REPORTED COMPLAINT REASON. THE RISK MANAGEMENT FILE WAS REVIEWED AND AN UPDATE WAS NOT DEEMED REQUIRED. A TECHNICAL INVESTIGATION OF THE COMPLAINT SAMPLE COULD NOT BE CONDUCTED, AS NO SAMPLE WAS AVAILABLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 23-APR-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 FALLOPIAN TUBE PERFORATION ('PERFORATION: FALLOPIAN TUBES / MIGRATION') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 882184) 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 UNDERWENT ESSURE CONFIRMATION TEST". ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), PELVIC PAIN ("PELVIC PAIN "), ABDOMINAL PAIN ("ABDOMINAL PAIN"), MENORRHAGIA ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)"), URINARY TRACT INFECTION ("URINARY TRACT INFECTION") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE") AND WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("HORMONAL IMBALANCE") AND WEIGHT INCREASED ("WEIGHT GAIN"). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, DYSMENORRHOEA, PELVIC PAIN, ABDOMINAL PAIN, MENORRHAGIA, URINARY TRACT INFECTION, VAGINAL DISCHARGE, HORMONE LEVEL ABNORMAL AND WEIGHT INCREASED OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, DYSMENORRHOEA, FALLOPIAN TUBE PERFORATION, HORMONE LEVEL ABNORMAL, MENORRHAGIA, PELVIC PAIN, URINARY TRACT INFECTION, VAGINAL DISCHARGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT RECEIVED TREATMENT FOR PAIN, URINARY TRACT INFECTION, VAGINAL DISCHARGE INSERTION DATE PROVIDED IN MR : (B)(6) 2011(DISCREPANCY NOTED). MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 12-APR-2021: MR RECEIVED : REPORTER, LOT NUMBER ADDED, RCC UPDATED. 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 FALLOPIAN TUBE PERFORATION ('PERFORATION: FALLOPIAN TUBES / 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 UNDERWENT ESSURE CONFIRMATION TEST". ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), PELVIC PAIN ("PELVIC PAIN "), ABDOMINAL PAIN ("ABDOMINAL PAIN"), MENORRHAGIA ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)"), URINARY TRACT INFECTION ("URINARY TRACT INFECTION") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE") AND WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("HORMONAL IMBALANCE") AND WEIGHT INCREASED ("WEIGHT GAIN"). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, DYSMENORRHOEA, PELVIC PAIN, ABDOMINAL PAIN, MENORRHAGIA, URINARY TRACT INFECTION, VAGINAL DISCHARGE, HORMONE LEVEL ABNORMAL AND WEIGHT INCREASED OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, DYSMENORRHOEA, FALLOPIAN TUBE PERFORATION, HORMONE LEVEL ABNORMAL, MENORRHAGIA, PELVIC PAIN, URINARY TRACT INFECTION, VAGINAL DISCHARGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT RECEIVED TREATMENT FOR PAIN, URINARY TRACT INFECTION, VAGINAL DISCHARGE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 11-SEP-2019: PFS RECEIVED: PREVIOUSLY REPORTED EVENT INJURY WERE UPDATED TO NEW EVENTS MIGRATION, PERFORATION: FALLOPIAN TUBES, DYSMENORRHEA (CRAMPING), PELVIC PAIN, ABDOMINAL PAIN, MENORRHAGIA (HEAVY MENSTRUAL BLEEDING), URINARY TRACT INFECTION, VAGINAL DISCHARGE, HORMONAL CHANGES, WEIGHT GAIN, PATIENT DID NOT UNDERWENT ESSURE. 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 |
|---|---|---|---|---|---|---|---|
| 929527 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 882184 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |