ESSURE
Report
- Report Number
- 2951250-2020-08110
- Event Type
- Injury
- Date Received
- May 22, 2020
- Report Date
- May 20, 2021
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE BREAKAGE ('SEPARATELY WITHIN THE SPECIMEN CONTAINER TWO SEGMENTS OF SILVER METALLIC COILED MATERIAL/ A PART WAS NOTED ON LEFT SIDE WHICH WAS REMOVED SUCCESSFULLY') AND DEVICE DISLOCATION ('MIGRATION') IN A 28-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. A25168) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED MULTIPAROUS. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: IUD NOS. CONCURRENT CONDITIONS INCLUDED ABNORMAL UTERINE BLEEDING, ABDOMINAL PAIN, NAUSEA, VOMITING, FITZ-HUGH-CURTIS SYNDROME, DYSURIA, OVARIAN CYST, ACUTE PYELONEPHRITIS AND MENORRHAGIA. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PSYCHOLOGICAL TRAUMA ("PSYCH INJURY"), PELVIC PAIN ("PAIN"), BLADDER DISORDER ("BLADDER PROBLEMS"), URINARY TRACT DISORDER ("URINARY PROBLEMS"), CYSTITIS ("BLADDER INFECTION"), URINARY TRACT INFECTION ("URINARY TRACT INFECTION"), VAGINAL INFECTION ("VAGINAL INFECTION") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). THE PATIENT WAS TREATED WITH SURGERY (SALPINGECTOMY - BILATERAL, HYSTERECTOMY -UTERUS + CERVIX). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE DEVICE BREAKAGE, DEVICE DISLOCATION AND PSYCHOLOGICAL TRAUMA OUTCOME WAS UNKNOWN AND THE PELVIC PAIN, BLADDER DISORDER, URINARY TRACT DISORDER, CYSTITIS, URINARY TRACT INFECTION, VAGINAL INFECTION AND VAGINAL DISCHARGE HAD RESOLVED. THE REPORTER CONSIDERED BLADDER DISORDER, CYSTITIS, DEVICE BREAKAGE, DEVICE DISLOCATION, PELVIC PAIN, PSYCHOLOGICAL TRAUMA, URINARY TRACT DISORDER, URINARY TRACT INFECTION, VAGINAL DISCHARGE AND VAGINAL INFECTION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: INSERTION DATE: (B)(6) 2012 (DISCREPANCY NOTED). THREE TRAILING COILS ON BOTH THE SIDES. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2013: COMPLETE OCCLUSION OF BOTH FALLOPIAN TUBES.. PREGNANCY TEST - ON (B)(6) 2016: NEGATIVE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS: DEVICE BREAKAGE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 26-APR-2021: MEDICAL RECORD RECEIVED. EVENT ADDED: SEPARATELY WITHIN THE SPECIMEN CONTAINER TWO SEGMENTS OF SILVER METALLIC COILED MATERIAL. LOT NUMBER, REPORTERS INFORMATION AND MEDICAL HISTORY WERE ADDED. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WAS CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ('MIGRATION') IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PSYCHOLOGICAL TRAUMA ("PSYCH INJURY"), PELVIC PAIN ("PAIN"), BLADDER DISORDER ("BLADDER PROBLEMS"), URINARY TRACT DISORDER ("URINARY PROBLEMS"), CYSTITIS ("BLADDER INFECTION"), URINARY TRACT INFECTION ("URINARY TRACT INFECTION"), VAGINAL INFECTION ("VAGINAL INFECTION") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE "). THE PATIENT WAS TREATED WITH SURGERY (SALPINGECTOMY - BILATERAL, HYSTERECTOMY -UTERUS + CERVIX). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION AND PSYCHOLOGICAL TRAUMA OUTCOME WAS UNKNOWN AND THE PELVIC PAIN, BLADDER DISORDER, URINARY TRACT DISORDER, CYSTITIS, URINARY TRACT INFECTION, VAGINAL INFECTION AND VAGINAL DISCHARGE HAD RESOLVED. THE REPORTER CONSIDERED BLADDER DISORDER, CYSTITIS, DEVICE DISLOCATION, PELVIC PAIN, PSYCHOLOGICAL TRAUMA, URINARY TRACT DISORDER, URINARY TRACT INFECTION, 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 (B)(6) 2020: QUALITY SAFETY EVALUATION OF PTC. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WAS CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE BREAKAGE ('SEPARATELY WITHIN THE SPECIMEN CONTAINER TWO SEGMENTS OF SILVER METALLIC COILED MATERIAL/ A PART WAS NOTED ON LEFT SIDE WHICH WAS REMOVED SUCCESSFULLY') AND DEVICE DISLOCATION ('MIGRATION') IN A 28-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. A25168) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED MULTIPAROUS. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: IUD NOS. CONCURRENT CONDITIONS INCLUDED ABNORMAL UTERINE BLEEDING, ABDOMINAL PAIN, NAUSEA, VOMITING, FITZ-HUGH-CURTIS SYNDROME, DYSURIA, OVARIAN CYST, ACUTE PYELONEPHRITIS AND MENORRHAGIA. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PSYCHOLOGICAL TRAUMA ("PSYCH INJURY"), PELVIC PAIN ("PAIN"), BLADDER DISORDER ("BLADDER PROBLEMS"), URINARY TRACT DISORDER ("URINARY PROBLEMS"), CYSTITIS ("BLADDER INFECTION"), URINARY TRACT INFECTION ("URINARY TRACT INFECTION"), VAGINAL INFECTION ("VAGINAL INFECTION") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE"). THE PATIENT WAS TREATED WITH SURGERY (SALPINGECTOMY - BILATERAL, HYSTERECTOMY -UTERUS + CERVIX). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE DEVICE BREAKAGE, DEVICE DISLOCATION AND PSYCHOLOGICAL TRAUMA OUTCOME WAS UNKNOWN AND THE PELVIC PAIN, BLADDER DISORDER, URINARY TRACT DISORDER, CYSTITIS, URINARY TRACT INFECTION, VAGINAL INFECTION AND VAGINAL DISCHARGE HAD RESOLVED. THE REPORTER CONSIDERED BLADDER DISORDER, CYSTITIS, DEVICE BREAKAGE, DEVICE DISLOCATION, PELVIC PAIN, PSYCHOLOGICAL TRAUMA, URINARY TRACT DISORDER, URINARY TRACT INFECTION, VAGINAL DISCHARGE AND VAGINAL INFECTION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: INSERTION DATE: (B)(6) 2012 (DISCREPANCY NOTED). THREE TRAILING COILS ON BOTH THE SIDES. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2013: COMPLETE OCCLUSION OF BOTH FALLOPIAN TUBES.. PREGNANCY TEST - ON (B)(6) 2016: NEGATIVE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS: DEVICE BREAKAGE. LOT NUMBER: A25168. MANUFACTURE DATE: 2012-07. EXPIRATION DATE: 2015-07. 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 10-MAY-2021: QUALITY SAFETY EVALUATION OF PTC. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WAS CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ('MIGRATION') IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PSYCHOLOGICAL TRAUMA ("PSYCH INJURY"), PELVIC PAIN ("PAIN"), BLADDER DISORDER ("BLADDER PROBLEMS"), URINARY TRACT DISORDER ("URINARY PROBLEMS"), CYSTITIS ("BLADDER INFECTION"), URINARY TRACT INFECTION ("URINARY TRACT INFECTION"), VAGINAL INFECTION ("VAGINAL INFECTION") AND VAGINAL DISCHARGE ("VAGINAL DISCHARGE "). THE PATIENT WAS TREATED WITH SURGERY (SALPINGECTOMY - BILATERAL, HYSTERECTOMY -UTERUS + CERVIX). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION AND PSYCHOLOGICAL TRAUMA OUTCOME WAS UNKNOWN AND THE PELVIC PAIN, BLADDER DISORDER, URINARY TRACT DISORDER, CYSTITIS, URINARY TRACT INFECTION, VAGINAL INFECTION AND VAGINAL DISCHARGE HAD RESOLVED. THE REPORTER CONSIDERED BLADDER DISORDER, CYSTITIS, DEVICE DISLOCATION, PELVIC PAIN, PSYCHOLOGICAL TRAUMA, URINARY TRACT DISORDER, URINARY TRACT INFECTION, 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 9-JAN-2020: PFS RECEIVED-PREVIOUSLY REPORTED EVENT INJURY NOS WAS REPLACED WITH PAIN. NEW EVENTS PSY INJURY , BLADDER PROBLEM , URINARY PROBLEM , BLADDER INFECTION ,VAGINAL INFECTION , VAGINAL DISCHARGE WERE ADDED. ESSURE REMOVAL DETAILS WERE ADDED. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WAS CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 547044 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | A25168 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 28 YR | Other| R |