ESSURE
Report
- Report Number
- 2951250-2020-00392
- Event Type
- Injury
- Date Received
- January 10, 2020
- Report Date
- February 19, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PAIN') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 872990) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. CO-SUSPECT PRODUCTS INCLUDED NITROGLYCERIN. THE PATIENT'S MEDICAL HISTORY INCLUDED LOW BACK PAIN, MYOFASCIAL PAIN SYNDROME, NUMBNESS OF LOWER EXTREMITIES, CANDIDA VAGINAL, SHOULDER PAIN, BRONCHITIS AND EAR PAIN. CONCURRENT CONDITIONS INCLUDED CANNABIS USE, NICOTINE DEPENDENCE, PSORIASIS, TRAUMA, AXILLARY PAIN, FIBROMYALGIA, FURUNCLE, NECK PAIN, ALLERGIC REACTION TO ANALGESICS, NECK CRAMPS, GERD, UPPER RESPIRATORY INFECTION, INTERMITTENT FEVER, CHILLS, SMOKER, CHEST PAIN, TEMPOROMANDIBULAR JOINT DISORDER NOS, UTERINE BLEEDING AND INGROWING NAIL. CONCOMITANT PRODUCTS INCLUDED CYCLOBENZAPRINE, ESOMEPRAZOLE, HYDROCODONE BITARTRATE;PARACETAMOL (NORCO), IBUPROFEN (MOTRIN), NSAIDS AND PARACETAMOL (TYLENOL). ON AN UNKNOWN DATE, THE PATIENT STARTED NITROGLYCERIN AT AN UNSPECIFIED DOSE AND FREQUENCY. 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 ("BLEEDING"), INFECTION ("INFECTION"), URINARY TRACT DISORDER ("URINARY PROBLEMS"), AUTOIMMUNE DISORDER ("AUTOIMMUNE-LIKE SYMPTOMS") AND MIGRAINE ("MIGRAINES"). THE PATIENT WAS TREATED WITH SURGERY (HYSTEROSCOPY AND BIOPSY OF UTERINE LESION, LAPAROSCOPIC SALPINGECTOMY, DILATION AND CURETTAGE). AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, INFECTION, URINARY TRACT DISORDER, AUTOIMMUNE DISORDER AND MIGRAINE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED AUTOIMMUNE DISORDER, GENITAL HAEMORRHAGE, INFECTION, MIGRAINE, PELVIC PAIN AND URINARY TRACT DISORDER TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: IMPRESSION: THE FALLOPIAN TUBE ARE OCCLUDED BY ESSURE DEVICE.. ULTRASOUND PELVIS - ON (B)(6) 2018: IMPRESSION: 1. SMALL FIBROID IN THE ANTERIOR UTERINE WALL. BILATERAL ESSURE DEVICES IN PLACE, THE LEFT EXTENDING MINIMALLY INTO THE UTERINE CAVITY. 2. NORMAL OVARIES.. LOT NUMBER: 872990, MANUFACTURING DATE: 2011-06, EXPIRATION DATE: 2014-06 . QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 7-FEB-2020: QUALITY-SAFETY EVALUATION OF PTC. A TECHNICAL INVESTIGATION WAS 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 ('PAIN') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 872990) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. CO-SUSPECT PRODUCTS INCLUDED NITROGLYCERIN. THE PATIENT'S MEDICAL HISTORY INCLUDED LOW BACK PAIN, MYOFASCIAL PAIN SYNDROME, NUMBNESS OF LOWER EXTREMITIES, CANDIDA VAGINAL, SHOULDER PAIN, BRONCHITIS AND EAR PAIN. CONCURRENT CONDITIONS INCLUDED CANNABIS USE, NICOTINE DEPENDENCE, PSORIASIS, TRAUMA, AXILLARY PAIN, FIBROMYALGIA, FURUNCLE, NECK PAIN, ALLERGIC REACTION TO ANALGESICS, NECK CRAMPS, GERD, UPPER RESPIRATORY INFECTION, INTERMITTENT FEVER, CHILLS, SMOKER, CHEST PAIN, TEMPOROMANDIBULAR JOINT DISORDER NOS, UTERINE BLEEDING AND INGROWING NAIL. CONCOMITANT PRODUCTS INCLUDED CYCLOBENZAPRINE, ESOMEPRAZOLE, HYDROCODONE BITARTRATE;PARACETAMOL (NORCO), IBUPROFEN (MOTRIN), NSAIDS AND PARACETAMOL (TYLENOL). ON AN UNKNOWN DATE, THE PATIENT STARTED NITROGLYCERIN AT AN UNSPECIFIED DOSE AND FREQUENCY. 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 ("BLEEDING"), INFECTION ("INFECTION"), URINARY TRACT DISORDER ("URINARY PROBLEMS"), AUTOIMMUNE DISORDER ("AUTOIMMUNE-LIKE SYMPTOMS") AND MIGRAINE ("MIGRAINES"). THE PATIENT WAS TREATED WITH SURGERY (HYSTEROSCOPY AND BIOPSY OF UTERINE LESION, LAPAROSCOPIC SALPINGECTOMY, DILATION AND CURETTAGE). AT THE TIME OF THE REPORT, THE PELVIC PAIN, GENITAL HAEMORRHAGE, INFECTION, URINARY TRACT DISORDER, AUTOIMMUNE DISORDER AND MIGRAINE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED AUTOIMMUNE DISORDER, GENITAL HAEMORRHAGE, INFECTION, MIGRAINE, PELVIC PAIN AND URINARY TRACT DISORDER TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM ON (B)(6) 2012: IMPRESSION: THE FALLOPIAN TUBE ARE OCCLUDED BY ESSURE DEVICE.. ULTRASOUND PELVIS ON (B)(6) 2018: IMPRESSION: SMALL FIBROID IN THE ANTERIOR UTERINE WALL. BILATERAL ESSURE DEVICES IN PLACE, THE LEFT EXTENDING MINIMALLY INTO THE UTERINE CAVITY. NORMAL OVARIES. 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 39138 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 872990 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R | CYCLOBENZAPRINE| CYCLOBENZAPRINE| ESOMEPRAZOLE| ESOMEPRAZOLE| MOTRIN [IBUPROFEN]| MOTRIN [IBUPROFEN]| NORCO| NORCO| NSAIDS| NSAIDS| TYLENOL| TYLENOL |