ESSURE
Report
- Report Number
- 2951250-2019-12295
- Event Type
- Injury
- Date Received
- December 13, 2019
- Report Date
- February 17, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('CHRONIC PELVIC PAIN') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 802744) 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 "SHE DID NOT UNDERWENT ESSURE CONFIRMATION TEST". THE PATIENT'S CONCURRENT CONDITIONS INCLUDED BLADDER INFECTION, UTI, FLANK PAIN, HEMATURIA, HOT FLASHES AND NIGHT SWEATS. FAMILY HISTORY INCLUDED OVARIAN NEOPLASM, HEART DISEASE, UNSPECIFIED, HYPERTENSION, HYPERTENSION, HYPERTENSION AND BREAST NEOPLASM. 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 ("GEN. ABNORM. BLEED"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), BACK PAIN ("BACK PAIN"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), MENORRHAGIA ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)"), NAUSEA ("NAUSEA"), MIGRAINE ("MIGRAINE"), HEADACHE ("HEADACHES"), INFECTION ("INFECTION") AND URINARY TRACT DISORDER ("URINARY PROBLEMS"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY(FULL),SALPINGECTOMY (BILATERAL)). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, ABDOMINAL PAIN, BACK PAIN, DYSPAREUNIA, MENORRHAGIA, NAUSEA, MIGRAINE, HEADACHE, INFECTION AND URINARY TRACT DISORDER OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, BACK PAIN, DYSPAREUNIA, GENITAL HAEMORRHAGE, HEADACHE, INFECTION, MENORRHAGIA, MIGRAINE, NAUSEA, PELVIC PAIN AND URINARY TRACT DISORDER TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DATE(S) OF INSERTION: (B)(6) 2011 (DISCREPANCY NOTED) (B)(6) 2011( IN PREVIOUS FOLLOW UP) PATIENT RECEIVED TREATMENT FOR: PELVIC PAIN, ABDOMINAL PAIN, BACK PAIN, DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), MENORRHAGIA (HEAVY MENSTRUAL BLEEDING), GEN. ABNORM. BLEED, NAUSEA, MIGRAINE AND HEADACHES MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2019: PLAINTIFF FACT SHEET AND MEDICAL RECORD WAS RECEIVED. LOT NUMBER WERE ADDED. EVENT ADDED FROM PFS- INFECTION, URINARY PROBLEMS. REPORTER INFORMATION, MEDICAL HISTORY WERE ADDED. 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 ('CHRONIC PELVIC PAIN') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 802744) 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 "SHE DID NOT UNDERWENT ESSURE CONFIRMATION TEST". THE PATIENT'S CONCURRENT CONDITIONS INCLUDED BLADDER INFECTION, UTI, FLANK PAIN, HEMATURIA, HOT FLASHES AND NIGHT SWEATS. FAMILY HISTORY INCLUDED OVARIAN NEOPLASM, HEART DISEASE, UNSPECIFIED, HYPERTENSION, HYPERTENSION, HYPERTENSION AND BREAST NEOPLASM. 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 ("GEN. ABNORM. BLEED"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), BACK PAIN ("BACK PAIN"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), MENORRHAGIA ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)"), NAUSEA ("NAUSEA"), MIGRAINE ("MIGRAINE"), HEADACHE ("HEADACHES"), INFECTION ("INFECTION") AND URINARY TRACT DISORDER ("URINARY PROBLEMS"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY(FULL),SALPINGECTOMY (BILATERAL)). ESSURE WAS REMOVED ON (B)(6)2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, ABDOMINAL PAIN, BACK PAIN, DYSPAREUNIA, MENORRHAGIA, NAUSEA, MIGRAINE, HEADACHE, INFECTION AND URINARY TRACT DISORDER OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, BACK PAIN, DYSPAREUNIA, GENITAL HAEMORRHAGE, HEADACHE, INFECTION, MENORRHAGIA, MIGRAINE, NAUSEA, PELVIC PAIN AND URINARY TRACT DISORDER TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DATE(S) OF INSERTION: (B)(6)2011 (DISCREPANCY NOTED) (B)(6)2011( IN PREVIOUS FOLLOW UP) PATIENT RECEIVED TREATMENT FOR: PELVIC PAIN, ABDOMINAL PAIN, BACK PAIN, DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), MENORRHAGIA (HEAVY MENSTRUAL BLEEDING), GEN. ABNORM. BLEED, NAUSEA, MIGRAINE AND HEADACHES 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 PELVIC PAIN ('CHRONIC PELVIC PAIN') AND GENITAL HAEMORRHAGE ('GEN. ABNORM. BLEED') 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 "SHE DID NOT UNDERWENT ESSURE CONFIRMATION TEST". 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 (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), ABDOMINAL PAIN ("ABDOMINAL PAIN"), BACK PAIN ("BACK PAIN"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), MENORRHAGIA ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)"), NAUSEA ("NAUSEA"), MIGRAINE ("MIGRAINE") AND HEADACHE ("HEADACHES"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY(FULL),SALPINGECTOMY (BILATERAL)). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, ABDOMINAL PAIN, BACK PAIN, DYSPAREUNIA, MENORRHAGIA, NAUSEA, MIGRAINE AND HEADACHE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, BACK PAIN, DYSPAREUNIA, GENITAL HAEMORRHAGE, HEADACHE, MENORRHAGIA, MIGRAINE, NAUSEA AND PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DATE(S) OF INSERTION: (B)(6) 2011 (DISCREPANCY NOTED) (B)(6) 2011( IN PREVIOUS FOLLOW UP). PATIENT RECEIVED TREATMENT FOR: PELVIC PAIN, ABDOMINAL PAIN, BACK PAIN, DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), MENORRHAGIA (HEAVY MENSTRUAL BLEEDING), GEN. ABNORM. BLEED, NAUSEA, MIGRAINE AND HEADACHES. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 27-NOV-2019: PFS RECEIVED. THIS CASE WAS UPGRADED TO INCIDENT. EVENT INJURY WAS UPDATED TO PELVIC PAIN, ABDOMINAL PAIN, BACK PAIN, DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), MENORRHAGIA (HEAVY MENSTRUAL BLEEDING), GEN. ABNORM. BLEED, NAUSEA, MIGRAINE, HEADACHES AND SHE DID NOT UNDERWENT ESSURE CONFIRMATION TEST. DATE OF EXPLANT WAS ADDED. REPORTER INFORMATION WAS 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 |
|---|---|---|---|---|---|---|---|
| 1260365 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 802744 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R |