FDA Adverse Event
Injury
Summary report: N
ESSURE
MDR report key: 3628411
·
Received February 14, 2014
Report
- Report Number
- MW5034449
- Event Type
- Injury
- Date Received
- February 14, 2014
- Date of Event
- December 1, 2010
- Report Date
- February 12, 2014
- Manufacturer
- BAYER
- Product Code
- HHS
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
(B)(4). FORGOT TO ADD ENDOMETRIAL CELLS PRESENT IN MOST RECENT PAP, CYSTS IN BREAST DETECTED IN MOST RECENT EXAM ALSO.
Description of Event or Problem · 1
STABBING PAIN IN BELLY BUTTON LASTING 10 DAYS PER MONTH CONTINUOUSLY, FATIGUE, SWIMMY HEAD, BLOATED, VITAMIN DEFICIENCY, THYROID, CONSTIPATION, NUMBNESS IN DIGITS, HEADACHES, BRAIN FOG, EYE WEAKNESS, SWOLLEN/SORE TOES, EAR RINGING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 97692 | ESSURE | HHS | BAYER |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 43.000 YR | Disability |