FDA Adverse Event
Injury
Summary report: N
ESSURE
MDR report key: 4251111
·
Received November 5, 2014
Report
- Report Number
- MW5039001
- Event Type
- Injury
- Date Received
- November 5, 2014
- Date of Event
- January 4, 2010
- Report Date
- November 5, 2014
- Product Code
- HHS
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- MI, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
I HAD THE ESSURE AND STARTING EXPERIENCING HORRIBLE ABDOMINAL PAINS, AFTER A COUPLE MONTHS. I HAD GONE BACK IN TO SEE MY OB/GYN AND THE IMPLANTS HAD ACTUALLY MIGRATED AND I NEEDED TO HAVE SURGERY TO REMOVE THEM AND MY TUBES REMOVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 710532 | ESSURE | ESSURE | HHS | 761616/774372 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 34 YR | Hospitalization| R |