ESSURE
Report
- Report Number
- 2951250-2019-08691
- Event Type
- Injury
- Date Received
- September 27, 2019
- Report Date
- May 7, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, 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. 882191) INSERTED FOR FEMALE STERILIZATION. 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), ABDOMINAL PAIN ("ABDOMINAL PAIN"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), BACK PAIN ("BACK PAIN"), MENORRHAGIA ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)") AND VAGINAL INFECTION ("VAGINAL INFECTION"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY(FULL)). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ABDOMINAL PAIN, DYSMENORRHOEA, BACK PAIN, MENORRHAGIA AND VAGINAL INFECTION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, BACK PAIN, DYSMENORRHOEA, MENORRHAGIA, PELVIC PAIN AND VAGINAL INFECTION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PLAINTIFF RECEIVED TREATMENT FOR PELVIC PAIN, ABDOMINAL PAIN, DYSMENORRHEA (CRAMPING), BACK PAIN, MENORRHAGIA (HEAVY MENSTRUAL BLEEDING). DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): IMAGING PROCEDURE - ON AN UNKNOWN DATE: ESSURE CONFIRMATION TEST (UNSPECIFIED) DONE. RESULT- NOT PROVIDED; ON AN UNKNOWN DATE: ESSURE CONFIRMATION TEST (UNSPECIFIED) DONE. RESULT- YES. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON(B)(6) 2020: LOT NUMBER 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 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. 882191) INSERTED FOR FEMALE STERILIZATION. 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), ABDOMINAL PAIN ("ABDOMINAL PAIN"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), BACK PAIN ("BACK PAIN"), MENORRHAGIA ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)") AND VAGINAL INFECTION ("VAGINAL INFECTION"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY(FULL)). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ABDOMINAL PAIN, DYSMENORRHOEA, BACK PAIN, MENORRHAGIA AND VAGINAL INFECTION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, BACK PAIN, DYSMENORRHOEA, MENORRHAGIA, PELVIC PAIN AND VAGINAL INFECTION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PLAINTIFF RECEIVED TREATMENT FOR PELVIC PAIN, ABDOMINAL PAIN, DYSMENORRHEA (CRAMPING), BACK PAIN, MENORRHAGIA (HEAVY MENSTRUAL BLEEDING). DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): IMAGING PROCEDURE - ON AN UNKNOWN DATE: ESSURE CONFIRMATION TEST (UNSPECIFIED) DONE. RESULT- NOT PROVIDED; ON AN UNKNOWN DATE: ESSURE CONFIRMATION TEST (UNSPECIFIED) DONE. RESULT- YES. LOT NUMBER: 882191 MANUFACTURING DATE: (B)(6) 2011. EXPIRATION DATE: 2014-07. 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. 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 STERILIZATION. 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), ABDOMINAL PAIN ("ABDOMINAL PAIN"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), BACK PAIN ("BACK PAIN"), MENORRHAGIA ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)") AND VAGINAL INFECTION ("VAGINAL INFECTION"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY(FULL)). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ABDOMINAL PAIN, DYSMENORRHOEA, BACK PAIN, MENORRHAGIA AND VAGINAL INFECTION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, BACK PAIN, DYSMENORRHOEA, MENORRHAGIA, PELVIC PAIN AND VAGINAL INFECTION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PLAINTIFF RECEIVED TREATMENT FOR PELVIC PAIN, ABDOMINAL PAIN, DYSMENORRHEA (CRAMPING), BACK PAIN, MENORRHAGIA (HEAVY MENSTRUAL BLEEDING). DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): IMAGING PROCEDURE ON AN UNKNOWN DATE: ESSURE CONFIRMATION TEST (UNSPECIFIED) DONE. RESULT- NOT PROVIDED. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. ON (B)(6) 2019: PLAINTIFF FACT SHEET RECEIVED. EVENT INJURY WAS UPDATED TO EVENTS: PELVIC PAIN, ABDOMINAL PAIN, DYSMENORRHEA (CRAMPING), BACK PAIN, MENORRHAGIA (HEAVY MENSTRUAL BLEEDING), VAGINAL INFECTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 923346 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 882191 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R |