FDA Adverse Event
Injury
Summary report: N
ESSURE
MDR report key: 4113518
·
Received September 24, 2014
Report
- Report Number
- MW5038265
- Event Type
- Injury
- Date Received
- September 24, 2014
- Date of Event
- August 15, 2006
- Report Date
- February 25, 2016
- Manufacturer
- BAYER
- Product Code
- HHS
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
(B)(4). STILL HAVING ALL THE SAME SYMPTOMS. NO MEDICATIONS HAVE IMPROVE MY CONDITION.
Description of Event or Problem · 1
#MEDWATCHER #(B)(4). ELEVATED SED RATE, ABNORMAL IGM LEVELS, MUSCLE AND JOINT PAIN, EXTREME FATIGUE, MIGRAINES, I HAVE A HA EVERY DAY. NUMBNESS AND TINGLING IN EXTREMITIES, DECREASE IN IMMUNE SYSTEM (I WAS NEVER SICK, NOW I'M SICK ALL THE TIME), STABBING ABDOMINAL PAIN LOWER QUADRANTS (APART FROM MENSTRUAL CRAMPS) HEAVY PERIODS, BLOOD CLOTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 596076 | ESSURE | HHS | BAYER |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 29.000 YR | Hospitalization |