ESSURE
Report
- Report Number
- 2951250-2019-06337
- Event Type
- Injury
- Date Received
- September 13, 2019
- Report Date
- November 12, 2019
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN') AND GENITAL HAEMORRHAGE ('BLEEDING') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 841528) 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. IN (B)(6) 2011, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("MENORRHAGIA"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)") AND ALLERGY TO METALS ("NICKEL ALLERGY"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND ABDOMINAL PAIN UPPER ("STOMACH PAIN"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (FULL),SALPINGECTOMY (BILATERAL) AND HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2013. AT THE TIME OF THE REPORT, THE PELVIC PAIN AND ABDOMINAL PAIN UPPER WAS RESOLVING, THE GENITAL HAEMORRHAGE, DYSMENORRHOEA AND DYSPAREUNIA HAD RESOLVED AND THE VAGINAL HAEMORRHAGE, MENORRHAGIA, FEMALE SEXUAL DYSFUNCTION AND ALLERGY TO METALS OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN UPPER, ALLERGY TO METALS, DYSMENORRHOEA, DYSPAREUNIA, FEMALE SEXUAL DYSFUNCTION, GENITAL HAEMORRHAGE, MENORRHAGIA, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT RECEIVED TREATMENT FOR DYSMENORRHEA (CRAMPING),DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE) DISCREPANCY NOTED IN ESSURE REMOVAL DATE 2013. LOT NUMBER: 841528 MANUFACTURE DATE: 2011-03 EXPIRATION DATE: 2014-03. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 13-NOV-2019: QUALITY SAFETY EVALUATION OF PTC. 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 NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, 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') AND GENITAL HAEMORRHAGE ('BLEEDING') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 841528) 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. IN (B)(6) 2011, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("MENORRHAGIA"), FEMALE SEXUAL DYSFUNCTION ("APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE)") AND ALLERGY TO METALS ("NICKEL ALLERGY"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND ABDOMINAL PAIN UPPER ("STOMACH PAIN"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (FULL),SALPINGECTOMY (BILATERAL) AND HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2013. AT THE TIME OF THE REPORT, THE PELVIC PAIN AND ABDOMINAL PAIN UPPER WAS RESOLVING, THE GENITAL HAEMORRHAGE, DYSMENORRHOEA AND DYSPAREUNIA HAD RESOLVED AND THE VAGINAL HAEMORRHAGE, MENORRHAGIA, FEMALE SEXUAL DYSFUNCTION AND ALLERGY TO METALS OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN UPPER, ALLERGY TO METALS, DYSMENORRHOEA, DYSPAREUNIA, FEMALE SEXUAL DYSFUNCTION, GENITAL HAEMORRHAGE, MENORRHAGIA, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT RECEIVED TREATMENT FOR DYSMENORRHEA (CRAMPING),DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE) DISCREPANCY NOTED IN ESSURE REMOVAL DATE 2013. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2019: PFS RECEIVED LOT NUMBER WAS ADDED. CASE BECAME INCIDENT. EVENTS "ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA), APAREUNIA (INABILITY TO HAVE SEXUAL INTERCOURSE),NICKEL ALLERGY, PELVIC PAIN, STOMACH PAIN" WERE ADDED. OUTCOME OF EVENTS " BLEEDING AND PAIN" WERE UPDATED AS RECOVERING. REPORTER INFORMATION WAS 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 NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF GENITAL HAEMORRHAGE ('BLEEDING') 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 GENITAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (FULL),SALPINGECTOMY (BILATERAL)). ESSURE WAS REMOVED ON (B)(6) 2013. AT THE TIME OF THE REPORT, THE GENITAL HAEMORRHAGE, DYSMENORRHOEA AND DYSPAREUNIA HAD RESOLVED. THE REPORTER CONSIDERED DYSMENORRHOEA, DYSPAREUNIA AND GENITAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT RECEIVED TREATMENT FOR DYSMENORRHEA (CRAMPING),DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE). QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 3-SEP-2019: PFS RECEIVED- PREVIOUSLY REPORTED EVENT "INJURY" IS REPLACED WITH "DYSMENORRHEA (CRAMPING)", EVENTS- "DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), BLEEDING, PATIENT DID NOT UNDERWENT ESSURE CONFIRMATION TEST, REPORTER ADDED. 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 |
|---|---|---|---|---|---|---|---|
| 815898 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 841528 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R |