ESSURE
Report
- Report Number
- 2951250-2020-07864
- Event Type
- Injury
- Date Received
- May 19, 2020
- Report Date
- June 16, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 863580) 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"), DYSPAREUNIA ("DYSPAREUNIA"), GENITAL HAEMORRHAGE ("GEN. ABNORMAL BLEEDING"), MENTAL DISORDER ("PSYCH INJURY"), URINARY TRACT INFECTION ("UTI"), BACTERIAL VAGINOSIS ("BACTERIAL VAGINOSIS"), VULVOVAGINAL CANDIDIASIS ("CANDIDA VAGINOSIS"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), MIGRAINE ("MIGRAINE"), HEADACHE ("HEADACHE") AND POST PROCEDURAL COMPLICATION ("POST REMOVAL COMPLICATIONS"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ABDOMINAL PAIN, BACK PAIN, DYSPAREUNIA, GENITAL HAEMORRHAGE, URINARY TRACT INFECTION, BACTERIAL VAGINOSIS, VULVOVAGINAL CANDIDIASIS, VAGINAL DISCHARGE, MIGRAINE AND HEADACHE HAD RESOLVED AND THE MENTAL DISORDER AND POST PROCEDURAL COMPLICATION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, BACK PAIN, BACTERIAL VAGINOSIS, DYSPAREUNIA, GENITAL HAEMORRHAGE, HEADACHE, MENTAL DISORDER, MIGRAINE, PELVIC PAIN, POST PROCEDURAL COMPLICATION, URINARY TRACT INFECTION, VAGINAL DISCHARGE AND VULVOVAGINAL CANDIDIASIS TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT RECEIVED TREATMENT FOR PELVIC PAIN, ABDOMINAL PAIN, BACK PAIN, DYSPAREUNIA, GEN. ABNORMAL BLEEDING, UTI, BACTERIAL VAGINOSIS, CANDIDA VAGINOSIS, VAGINAL DISCHARGE, MIGRAINE, HEADACHE . LOT NUMBER: 863580 MANUFACTURING DATE: 2011-05 EXPIRATION DATE: 2014-05 . QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 4-JUN-2020: 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') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 863580) 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"), DYSPAREUNIA ("DYSPAREUNIA"), GENITAL HAEMORRHAGE ("GEN. ABNORMAL BLEEDING"), MENTAL DISORDER ("PSYCH INJURY"), URINARY TRACT INFECTION ("UTI"), BACTERIAL VAGINOSIS ("BACTERIAL VAGINOSIS"), VULVOVAGINAL CANDIDIASIS ("CANDIDA VAGINOSIS"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), MIGRAINE ("MIGRAINE"), HEADACHE ("HEADACHE") AND POST PROCEDURAL COMPLICATION ("POST REMOVAL COMPLICATIONS"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ABDOMINAL PAIN, BACK PAIN, DYSPAREUNIA, GENITAL HAEMORRHAGE, URINARY TRACT INFECTION, BACTERIAL VAGINOSIS, VULVOVAGINAL CANDIDIASIS, VAGINAL DISCHARGE, MIGRAINE AND HEADACHE HAD RESOLVED AND THE MENTAL DISORDER AND POST PROCEDURAL COMPLICATION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, BACK PAIN, BACTERIAL VAGINOSIS, DYSPAREUNIA, GENITAL HAEMORRHAGE, HEADACHE, MENTAL DISORDER, MIGRAINE, PELVIC PAIN, POST PROCEDURAL COMPLICATION, URINARY TRACT INFECTION, VAGINAL DISCHARGE AND VULVOVAGINAL CANDIDIASIS TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT RECEIVED TREATMENT FOR PELVIC PAIN, ABDOMINAL PAIN, BACK PAIN, DYSPAREUNIA, GEN. ABNORMAL BLEEDING, UTI, BACTERIAL VAGINOSIS, CANDIDA VAGINOSIS, VAGINAL DISCHARGE, MIGRAINE, HEADACHE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 9-JAN-2020: PIF RECEIVED. LOT NUMBER ADDED. REPORTER INFORMATION WERE 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN') 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"), DYSPAREUNIA ("DYSPAREUNIA"), GENITAL HAEMORRHAGE ("GEN. ABNORMAL BLEEDING"), MENTAL DISORDER ("PSYCH INJURY"), URINARY TRACT INFECTION ("UTI"), BACTERIAL VAGINOSIS ("BACTERIAL VAGINOSIS"), VULVOVAGINAL CANDIDIASIS ("CANDIDA VAGINOSIS"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), MIGRAINE ("MIGRAINE"), HEADACHE ("HEADACHE") AND POST PROCEDURAL COMPLICATION ("POST REMOVAL COMPLICATIONS"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ABDOMINAL PAIN, BACK PAIN, DYSPAREUNIA, GENITAL HAEMORRHAGE, URINARY TRACT INFECTION, BACTERIAL VAGINOSIS, VULVOVAGINAL CANDIDIASIS, VAGINAL DISCHARGE, MIGRAINE AND HEADACHE HAD RESOLVED AND THE MENTAL DISORDER AND POST PROCEDURAL COMPLICATION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, BACK PAIN, BACTERIAL VAGINOSIS, DYSPAREUNIA, GENITAL HAEMORRHAGE, HEADACHE, MENTAL DISORDER, MIGRAINE, PELVIC PAIN, POST PROCEDURAL COMPLICATION, URINARY TRACT INFECTION, VAGINAL DISCHARGE AND VULVOVAGINAL CANDIDIASIS TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT RECEIVED TREATMENT FOR PELVIC PAIN, ABDOMINAL PAIN, BACK PAIN, DYSPAREUNIA, GEN. ABNORMAL BLEEDING, UTI, BACTERIAL VAGINOSIS, CANDIDA VAGINOSIS, VAGINAL DISCHARGE, MIGRAINE, HEADACHE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 5-MAY-2020: PFS RECEIVED : PREVIOUSLY REPORTED EVENT "INJURY TO HERSELF" UPDATED TO "PELVIC PAIN", EVENTS- " ABDOMINAL PAIN, BACK PAIN, DYSPAREUNIA, GEN. ABNORMAL BLEEDING, PSYCH INJURY, UTI, BACTERIAL VAGINOSIS, CANDIDA VAGINOSIS, VAGINAL DISCHARGE, MIGRAINE, HEADACHE, POST REMOVAL COMPLICATIONS " 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 |
|---|---|---|---|---|---|---|---|
| 533161 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 863580 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R |