ESSURE
Report
- Report Number
- 2951250-2019-05575
- Event Type
- Injury
- Date Received
- September 6, 2019
- Date of Event
- March 1, 2012
- Report Date
- October 23, 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 ('PELVIC PAIN/ PELVIS PAIN') IN A 24-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. D140937-NOT VALID) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. CONCOMITANT PRODUCTS INCLUDED SALBUTAMOL (ALBUTEROL). ON (B)(6)2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6)2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN ("ABDOMINAL PAIN"), MENORRHAGIA ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)/ ABNORMAL BLEEDING (MENORRHAGIA)/ HEAVY BLEEDING"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND MENSTRUATION IRREGULAR ("IRREGULAR PERIODS") AND WAS FOUND TO HAVE UTERINE LEIOMYOMA ("SLIGHTLY ENLARGED FIBROID UTERUS"). THE PATIENT WAS TREATED WITH SURGERY (SALPINGECTOMY (BILATERAL)). ESSURE WAS REMOVED ON (B)(6)2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ABDOMINAL PAIN, DYSMENORRHOEA, MENORRHAGIA AND MENSTRUATION IRREGULAR HAD RESOLVED AND THE UTERINE LEIOMYOMA AND VAGINAL HAEMORRHAGE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, DYSMENORRHOEA, MENORRHAGIA, MENSTRUATION IRREGULAR, PELVIC PAIN, UTERINE LEIOMYOMA AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT RECEIVED TREATMENT FOR ABDOMINAL PAIN, DYSMENORRHEA (CRAMPING), MENORRHAGIA (HEAVY MENSTRUAL BLEEDING) AND SLIGHTLY ENLARGED FIBROID UTERUS. CURRENT WEIGHT 192 LBS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY WEIGHT WAS REPORTED TO BE 71.202 KGS. HYSTEROSALPINGOGRAM - ON (B)(6)2012: BILATERAL OCCLUSION. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS: DYSMENORRHEA, PELVIC PAIN. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 9-OCT-2019: UPDATE OF INFORMATION (BATCH IS NOT VALID) INCIDENT: NO VALID 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN/ PELVIS PAIN') IN A 24-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. D140937) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. CONCOMITANT PRODUCTS INCLUDED SALBUTAMOL (ALBUTEROL). ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN MARCH 2012, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND DYSMENORRHOEA ("DYSMENNORHEA (CRAMPING)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN ("ABDOMINAL PAIN"), MENORRHAGIA ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)/ ABNORMAL BLEEDING (MENORRHAGIA)/ HEAVY BLEEDING"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND MENSTRUATION IRREGULAR ("IRREGULAR PERIODS") AND WAS FOUND TO HAVE UTERINE LEIOMYOMA ("SLIGHTLY ENLARGED FIBROID UTERUS"). THE PATIENT WAS TREATED WITH SURGERY (SALPINGECTOMY (BILATERAL)). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ABDOMINAL PAIN, DYSMENORRHOEA, MENORRHAGIA AND MENSTRUATION IRREGULAR HAD RESOLVED AND THE UTERINE LEIOMYOMA AND VAGINAL HAEMORRHAGE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, DYSMENORRHOEA, MENORRHAGIA, MENSTRUATION IRREGULAR, PELVIC PAIN, UTERINE LEIOMYOMA AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT RECEIVED TREATMENT FOR ABDOMINAL PAIN, DYSMENNORHEA (CRAMPING), MENORRHAGIA (HEAVY MENSTRUAL BLEEDING) AND SLIGHTLY ENLARGED FIBROID UTERUS. CURRENT WEIGHT 192 LBS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY WEIGHT WAS REPORTED TO BE 71.202 KGS. HYSTEROSALPINGOGRAM - ON (B)(6) 2012: BILATERAL OCCLUSION. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS: DYSMENNORHEA, PELVIC PAIN. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 19-SEP-2019: PLAINTIFF FACT SHEET AND MEDICAL RECORD WAS RECEIVED. LOT NUMBER WERE ADDED. EVENTS ADDED FROM PFS- ABNORMAL BLEEDING (VAGINAL), IRREGULAR PERIODS. REPORTER INFORMATION, CONCOMITANT DRUG, EVENTS OUTCOMES, EVENTS ONSET DATE 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.
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) 2012, 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 ("DYSMENNORHEA (CRAMPING)") AND MENORRHAGIA ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)") AND WAS FOUND TO HAVE UTERINE LEIOMYOMA ("SLIGHTLY ENLARGED FIBROID UTERUS"). THE PATIENT WAS TREATED WITH SURGERY (SALPINGECTOMY (BILATERAL)). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ABDOMINAL PAIN, DYSMENORRHOEA AND MENORRHAGIA HAD RESOLVED AND THE UTERINE LEIOMYOMA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, DYSMENORRHOEA, MENORRHAGIA, PELVIC PAIN AND UTERINE LEIOMYOMA TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT RECEIVED TREATMENT FOR ABDOMINAL PAIN, DYSMENNORHEA (CRAMPING), MENORRHAGIA (HEAVY MENSTRUAL BLEEDING) AND SLIGHTLY ENLARGED FIBROID UTERUS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): IMAGING PROCEDURE - ON (B)(6) 2012: BILATERAL OCCLUSION. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 30-AUG-2019: PFS RECEIVED: CASE HAS BECAME INCIDENT. PREVIOUSLY REPORTED EVENT INJURY NOS WAS REPLACED WITH NEW EVENTS- PELVIC PAIN, ABDOMINAL PAIN, DYSMENORRHEA (CRAMPING), MENORRHAGIA (HEAVY MENSTRUAL BLEEDING) AND SLIGHTLY ENLARGED FIBROID UTERUS. REPORTER INFORMATION WERE UPDATED AND LAB DATA WERE ADDED. INCIDENT 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 |
|---|---|---|---|---|---|---|---|
| 763246 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | D140937-NOT VALID | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 24 YR | Other| R | ALBUTEROL [SALBUTAMOL]| ALBUTEROL [SALBUTAMOL] |