FDA Adverse Event
Injury
Summary report: N
ESSURE
MDR report key: 5723009
·
Received June 14, 2016
Report
- Report Number
- MW5062831
- Event Type
- Injury
- Date Received
- June 14, 2016
- Date of Event
- July 17, 2013
- Report Date
- June 13, 2016
- Manufacturer
- BAYER
- Product Code
- HHS
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
(B)(4). DEVICE PROVIDED BY INSURER. I HAVE HAD HEADACHES, MIGRAINES, IRREGULAR PERIODS, BRAIN FOG, ANXIETY, INSOMNIA, JOINT PAIN, RINGING IN MY EARS, PAINFUL PERIODS, CLOTTY PERIODS, ANGER, LITTLE SEX DRIVE, PELVIC PAIN.. I'M SURE I'M MISSING SOME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 377140 | ESSURE | HHS | BAYER |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 32.000 YR | Other |