FDA Adverse Event
Injury
Summary report: N
ESSURE
MDR report key: 2181190
·
Received July 21, 2011
Report
- Report Number
- 2951250-2011-00044
- Event Type
- Injury
- Date Received
- July 21, 2011
- Report Date
- January 19, 2017
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DATA CORRECTION FOR US REPORTING: THE CODE KNH WAS REPLACED WITH HHS
Description of Event or Problem · 1
REPORT OF CHRONIC PELVIC PAIN BEING EXPERIENCE FOR 1-YEAR. PAIN BEGAN POST-ESSURE PLACEMENT AND DOCTOR REPORTS THAT PATIENT DENIES ANY HISTORY OF PAIN PRIOR TO ESSURE PLACEMENT. THE PHYSICIAN PERFORMED LAPAROSCOPIC HYSTERECTOMY WITH BILATERAL SALPINGECTOMY. AT THE TIME OF LAPAROSCOPY, THE LEFT ESSURE COIL WAS NOTED TO HAVE PERFORATED THE LEFT CORNUA. PHYSICIAN CONCLUDED THAT THE PAIN IS MOST LIKELY ASSOCIATED WITH THE PERFORATION CAUSED BY ESSURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ESSURE | INSERT, TUBAL OCCLUSION | HHS | BAYER PHARMA AG | ESS305 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 37 YR | Required Intervention |