FDA Adverse Event
Injury
Summary report: N
BAYER
MDR report key: 3255591
·
Received July 24, 2013
Report
- Report Number
- MW5031161
- Event Type
- Injury
- Date Received
- July 24, 2013
- Date of Event
- July 24, 2013
- Report Date
- July 24, 2013
- Manufacturer
- BAYER AG
- Product Code
- HHS
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- NY, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
I HAVE GOTTEN THE ESSURE PROCEDURE DONE IN (B)(6) 2012 AND IT IS (B)(6) 2013. CURRENTLY I HAVE SUFFERED REALLY BAD HEADACHES AND LOTS OF PELVIC PAIN. I DON'T KNOW WHO TO GO TO OR WHO TO TURN TO. DIAGNOSIS OR REASON FOR USE: BLOOD TYPE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 346591 | BAYER | ESSURE | HHS | BAYER AG |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 22 YR | Other |