FDA Adverse Event
Injury
Summary report: N
ESSURE
MDR report key: 4661703
·
Received April 6, 2015
Report
- Report Number
- MW5041830
- Event Type
- Injury
- Date Received
- April 6, 2015
- Date of Event
- March 24, 2015
- Report Date
- October 20, 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). HAIR LOSS, SERVER FATIGUE, HAND FEET SWELL. PREGNANT YEAR LATER AFTER BEING CONFIRMED BLOCKED. CHRONIC PAIN, INFLAMMATION, DEPRESSION, ANXIETY, HIVES. HYSTERECTOMY.
Description of Event or Problem · 1
(B)(4). IT'S AMAZING HOW GETTING THE ESSURE REMOVED FROM YOUR BODY CAN MAKE YOU FEEL. I NO LONGER HAVE HOT FLASHES, NIGHT SWEATS, HIVES, ITCHY SKIN, MY HAIR IS NO LONGER COMING OUT IN GABS. I'M NO LONGER ON ANTI DEPRESSANTS. AND THE CHRONIC BACK PAIN I HAD IS GONE. ESSURE DOES NOT WORK. I'M PROVE. PREGNANT YEAR AFTER IMPLANT AND BEING CONFIRMED BLOCKED. THEN YEARS LATER A MIGRATED COIL. HOW CAN YOU ALLOW THIS TO REMAIN ON THE MARKET. SINCERELY, (B)(6).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 225605 | ESSURE | HHS | BAYER |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 39.000 YR | Hospitalization| O| R |