FDA Adverse Event
Injury
Summary report: N
ESSURE
MDR report key: 3983229
·
Received August 6, 2014
Report
- Report Number
- MW5037600
- Event Type
- Injury
- Date Received
- August 6, 2014
- Date of Event
- April 4, 2013
- Report Date
- August 2, 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). I SUFFER FROM PAINFUL PERIODS, CYSTS ON MY OVARIES THAT CAUSE SERIOUS PAIN UNTIL THEY RUPTURE WHICH I CAN FEEL HAPPEN, PELVIC PAIN, PAIN ALL OVER MY STOMACH, TENDER BREASTS, MIGRAINES, FOUL TASTE IN MY MOUTH, HAIR THINNING, ANGER, SADNESS, LOTS OF MOOD SWINGS, ACNE, PAIN IN MY KIDNEYS, RESTLESS LEG SYNDROME, MEMORY FOG, TROUBLE CONCENTRATING, RINGING IN MY EARS, CONSTIPATION. AND I REALLY CAN'T STRESS ENOUGH ALL THE STOMACH PAIN I HAVE. I FEEL LIKE I'VE BEEN POISONED AND PAINS SHOOT THROUGHOUT MY WHOLE UPPER BODY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 461929 | ESSURE | HHS | BAYER |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 30.000 YR | Other | I HAVE ESSURE AND FILSHY CLIPS |