FDA Adverse Event
Injury
Summary report: N
ESSURE
MDR report key: 4922776
·
Received July 17, 2015
Report
- Report Number
- MW5044304
- Event Type
- Injury
- Date Received
- July 17, 2015
- Date of Event
- January 7, 2014
- Report Date
- May 22, 2017
- Manufacturer
- BAYER
- Product Code
- HHS
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
(B)(4). IT NOW HAS BEEN EIGHT WEEKS SINCE I HAD THE ESSURE REMOVED AND A HYSTERECTOMY. I INSTANTLY STOPPED HAVING MIGRAINES. MY ANXIETY DIMINISHED. ESSURE SEEMS TO BE NOTHING BUT POISON TO THE BODY . FEELING BLESSED I HAD A GREAT OUTCOME. TAKE THIS PRODUCT OFF THE MARKET BEFORE IT DESTROYS OTHERS LIVES. STILL MENTALLY RECOVERING.
Description of Event or Problem · 1
(B)(4). I AM STILL BLEEDING EVERY TWO WEEKS WITH SPOTTING IN BETWEEN . I FEEL TIRED AND HAVE HAIR LOSS.
Description of Event or Problem · 1
(B)(4). IT HAS BEEN A YEAR SINCE MY HYSTERECTOMY AND I STILL WAS LEFT WITH BOTH OVARIES. I HAD THE RIGHT OVARY REMOVED FOR IT WAS CAUSING PAIN . I NOW SEEM TO BE PAIN FREE. NOW DEALING WITH EARLY MENOPAUSE AND MY TEETH SEEM TO NOT BREAK AS MUCH . ANXIETY IS STILL THERE. ..
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 466365 | ESSURE | HHS | BAYER |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45.000 YR | Other |