ESSURE
Report
- Report Number
- 2951250-2020-08195
- Event Type
- Injury
- Date Received
- May 28, 2020
- Report Date
- May 18, 2021
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MS, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PAIN') AND ENDOMETRITIS ('CHRONIC ENDOMETRITIS') IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 882191) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ENDOMETRITIS (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING"), THE FIRST EPISODE OF HYPERSENSITIVITY ("ALLERGY REACTION"), PSYCHOLOGICAL TRAUMA ("PSYCHOLOGICAL INJURY"), BLADDER DISORDER ("BLADDER DISORDER"), URINARY TRACT DISORDER ("URINARY PROBLEMS"), CYSTITIS ("BLADDER INFECTION"), URINARY TRACT INFECTION ("UTI"), VAGINAL INFECTION ("VAGINAL INFECTION"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE") AND THE SECOND EPISODE OF HYPERSENSITIVITY ("ALLERGY REACTION"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY BILATERAL AND TOTAL LAPAROSCOPIC HYSTERECTOMY, BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE PELVIC PAIN, BLADDER DISORDER, URINARY TRACT DISORDER AND THE LAST EPISODE OF HYPERSENSITIVITY HAD RESOLVED AND THE ENDOMETRITIS, GENITAL HAEMORRHAGE, PSYCHOLOGICAL TRAUMA, CYSTITIS, URINARY TRACT INFECTION, VAGINAL INFECTION AND VAGINAL DISCHARGE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED BLADDER DISORDER, CYSTITIS, ENDOMETRITIS, GENITAL HAEMORRHAGE, PELVIC PAIN, PSYCHOLOGICAL TRAUMA, URINARY TRACT DISORDER, URINARY TRACT INFECTION, VAGINAL DISCHARGE, VAGINAL INFECTION, THE FIRST EPISODE OF HYPERSENSITIVITY AND THE SECOND EPISODE OF HYPERSENSITIVITY TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT RECEIVED TREATMENT FOR PAIN,BLEEDING TRAILING COILS- RIGHT-APPROXIMATELY THREE TO FOUR RINGS, LEFT- APPROXIMATELY THREE RINGS. LOT NUMBER: 882191, MANUFACTURING 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 5-MAY-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 ('PAIN') AND ENDOMETRITIS ('CHRONIC ENDOMETRITIS'). IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 882191), INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ENDOMETRITIS (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING"). THE FIRST EPISODE OF HYPERSENSITIVITY ("ALLERGY REACTION"), PSYCHOLOGICAL TRAUMA ("PSYCHOLOGICAL INJURY"), BLADDER DISORDER ("BLADDER DISORDER"), URINARY TRACT DISORDER ("URINARY PROBLEMS"), CYSTITIS ("BLADDER INFECTION"), URINARY TRACT INFECTION ("UTI"), VAGINAL INFECTION ("VAGINAL INFECTION"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). AND THE SECOND EPISODE OF HYPERSENSITIVITY ("ALLERGY REACTION"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY BILATERAL AND TOTAL LAPAROSCOPIC HYSTERECTOMY, BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE PELVIC PAIN, BLADDER DISORDER, URINARY TRACT DISORDER AND THE LAST EPISODE OF HYPERSENSITIVITY HAD RESOLVED. AND THE ENDOMETRITIS, GENITAL HAEMORRHAGE, PSYCHOLOGICAL TRAUMA, CYSTITIS, URINARY TRACT INFECTION, VAGINAL INFECTION AND VAGINAL DISCHARGE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED BLADDER DISORDER, CYSTITIS, ENDOMETRITIS, GENITAL HAEMORRHAGE, PELVIC PAIN, PSYCHOLOGICAL TRAUMA, URINARY TRACT DISORDER, URINARY TRACT INFECTION, VAGINAL DISCHARGE, VAGINAL INFECTION, THE FIRST EPISODE OF HYPERSENSITIVITY AND THE SECOND EPISODE OF HYPERSENSITIVITY TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT RECEIVED TREATMENT FOR PAIN, BLEEDING. TRAILING COILS: RIGHT: APPROXIMATELY THREE TO FOUR RINGS, LEFT: APPROXIMATELY THREE RINGS. QUALITY SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2021, MR RECEIVED EVENT "CHRONIC ENDOMETRITIS", REPORTER 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 PELVIC PAIN ('PAIN') IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 882191) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING"), THE FIRST EPISODE OF HYPERSENSITIVITY ("ALLERGY REACTION"), PSYCHOLOGICAL TRAUMA ("PSYCHOLOGICAL INJURY"), BLADDER DISORDER ("BLADDER DISORDER"), URINARY TRACT DISORDER ("URINARY PROBLEMS"), CYSTITIS ("BLADDER INFECTION"), URINARY TRACT INFECTION ("UTI"), VAGINAL INFECTION ("VAGINAL INFECTION"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE") AND THE SECOND EPISODE OF HYPERSENSITIVITY ("ALLERGY REACTION"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY BILATERAL). ESSURE WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE PELVIC PAIN, BLADDER DISORDER, URINARY TRACT DISORDER AND THE LAST EPISODE OF HYPERSENSITIVITY HAD RESOLVED AND THE GENITAL HAEMORRHAGE, PSYCHOLOGICAL TRAUMA, CYSTITIS, URINARY TRACT INFECTION, VAGINAL INFECTION AND VAGINAL DISCHARGE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED BLADDER DISORDER, CYSTITIS, GENITAL HAEMORRHAGE, PELVIC PAIN, PSYCHOLOGICAL TRAUMA, URINARY TRACT DISORDER, URINARY TRACT INFECTION, VAGINAL DISCHARGE, VAGINAL INFECTION, THE FIRST EPISODE OF HYPERSENSITIVITY AND THE SECOND EPISODE OF HYPERSENSITIVITY TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT RECEIVED TREATMENT FOR PAIN,BLEEDING. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 9-JAN-2020: PFS RECEIVED. NEW EVENTS:PAIN, ABNORMAL BLEEDING, PSYCHOLOGICAL INJURY, BLADDER DISORDER, URINARY PROBLEMS, UTI, BLADDER INFECTION, BLADDER INFECTION, VAGINAL DISCHARGE, ALLERGY REACTION WAS ADDED. NEW REPORTER ADDED. 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 560494 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 882191 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R |