FDA Adverse Event
Injury
Summary report: N
ESSURE
MDR report key: 5080838
·
Received September 12, 2015
Report
- Report Number
- MW5056191
- Event Type
- Injury
- Date Received
- September 12, 2015
- Date of Event
- September 30, 2009
- Report Date
- September 12, 2015
- Manufacturer
- BAYER
- Product Code
- HHS
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- FL, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
HAD A HYSTERECTOMY AT AGE 33 DUE TO ESSURE. I WAS ALWAYS IN SUFFERING VERY PAINFUL PERIODS, PAINFUL SEX, HEADACHES, LEFT LEG PAIN, BODY RASHES SINCE THE DOCTOR TOOK ESSURE OUT I FEEL MUCH BETTER NO MORE PAIN THANK GOD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 604440 | ESSURE | ESSURE | HHS | BAYER |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 28 YR | Hospitalization| O| R |