FDA Adverse Event
Injury
Summary report: N
ESSURE
MDR report key: 5261156
·
Received December 2, 2015
Report
- Report Number
- MW5058226
- Event Type
- Injury
- Date Received
- December 2, 2015
- Date of Event
- September 18, 2015
- Report Date
- December 1, 2015
- Manufacturer
- BAYER
- Product Code
- HHS
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
(B)(4). I ENDED UP HAVING CYST ON MY OVARIES, THANK GOD THEY WERE BENIGN, AND ALSO HAVE ARTHRITIS IN MY BACK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 789982 | ESSURE | HHS | BAYER |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 34.000 YR | Other |