ESSURE
Report
- Report Number
- 2951250-2019-03361
- Event Type
- Injury
- Date Received
- July 5, 2019
- Report Date
- July 10, 2019
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PAIN') AND MENORRHAGIA ('MENORRHAGIA') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (ESS205) (BATCH NO. 509790) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED FIBROMYALGIA, PAP SMEAR ABNORMAL, UTERINE ABLATION AND ELECTIVE ABORTION. CONCURRENT CONDITIONS INCLUDED POLYMENORRHEA, MULTIGRAVIDA, PARITY 2, UTERINE BLEEDING AND DYSURIA. ON (B)(6) 2006, THE PATIENT HAD ESSURE (ESS205) INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND FATIGUE ("FATIGUE") AND WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES : NO EXPLANATION PROVIDED"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (PARTIAL) PATIENT STATES SHE STILL HAS OVARIES AND ABLATION). ESSURE (ESS205) WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, HORMONE LEVEL ABNORMAL, MIGRAINE, HEADACHE, DYSPAREUNIA AND FATIGUE OUTCOME WAS UNKNOWN AND THE MENORRHAGIA, VAGINAL HAEMORRHAGE AND DYSMENORRHOEA HAD RESOLVED. THE REPORTER CONSIDERED DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, HEADACHE, HORMONE LEVEL ABNORMAL, MENORRHAGIA, MIGRAINE, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE (ESS205). THE REPORTER COMMENTED: DATE(S) OF INSERTION: (B)(6) 2006 AS PER PFS. THE POSITION OF THE DEVICE WAS CONFIRMED WITH 6 COILS TRAILING ON THE LEFT SIDE . THE SAME PROCESS WAS REPEATED ON THE OPPOSITE SIDE WITH 5 COILS TRAILING ON THE RIGHT SIDE. RIGHT TUBE OF COILS 5 LEFT TUBE OF COILS 3 DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2006: BILATERAL ESSURE MICRO INSERTS IN SATISFACTORY POSITION. NO CONTRAST ENTERS THE FALLOPIAN TUBES BILATERALLY IMPLYING TUBAL OCCLUSION AT THE CORNUA. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2019: QUALITY SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT 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-CONFORMANCE'S 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 ('PAIN') AND MENORRHAGIA ('MENORRHAGIA') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (ESS205) (BATCH NO. 509790) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED FIBROMYALGIA, PAP SMEAR ABNORMAL, UTERINE ABLATION AND ELECTIVE ABORTION. CONCURRENT CONDITIONS INCLUDED POLYMENORRHEA, GRAVIDA II, PARITY 2, UTERINE BLEEDING AND DYSURIA. ON (B)(6) 2006, THE PATIENT HAD ESSURE (ESS205) INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)") AND FATIGUE ("FATIGUE") AND WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES: NO EXPLANATION PROVIDED"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (PARTIAL) PATIENT STATES SHE STILL HAS OVARIES AND ABLATION). ESSURE (ESS205) WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, HORMONE LEVEL ABNORMAL, MIGRAINE, HEADACHE, DYSPAREUNIA AND FATIGUE OUTCOME WAS UNKNOWN AND THE MENORRHAGIA, VAGINAL HAEMORRHAGE AND DYSMENORRHOEA HAD RESOLVED. THE REPORTER CONSIDERED DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, HEADACHE, HORMONE LEVEL ABNORMAL, MENORRHAGIA, MIGRAINE, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE (ESS205). THE REPORTER COMMENTED: DATE(S) OF INSERTION: (B)(6) 2006 AS PER PFS. THE POSITION OF THE DEVICE WAS CONFIRMED WITH 6 COILS TRAILING ON THE LEFT SIDE . THE SAME PROCESS WAS REPEATED ON THE OPPOSITE SIDE WITH 5 COILS TRAILING ON THE RIGHT SIDE. RIGHT TUBE OF COILS 5, LEFT TUBE OF COILS 3. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2006: BILATERAL ESSURE MICRO INSERTS IN SATISFACTORY POSITION. NO CONTRAST ENTERS THE FALLOPIAN TUBES BILATERALLY IMPLYING TUBAL OCCLUSION AT THE CORNUA. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 26-JUN-2019: PFS RECEIVED. CASE BECOMES VALID. LOT NUMBER AND LAB DATA ADDED. CONCOMITANT CONDITION ADDED. EVENTS; PAIN, MENORRHAGIA, ABNORMAL BLEEDING (VAGINAL), HORMONAL CHANGES : NO EXPLANATION PROVIDED, MIGRAINES, HEADACHES, DYSMENORRHEA (CRAMPING), DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), FATIGUE WERE ADDED. INCIDENT 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 557153 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS205 | 509790 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R |