FDA Adverse Event
Injury
Summary report: N
MINIARC SINGLE-INCISION SLING
MDR report key: 2963439
·
Received February 13, 2013
Report
- Report Number
- 2183959-2013-00683
- Event Type
- Injury
- Date Received
- February 13, 2013
- Report Date
- December 31, 2012
- Manufacturer
- AMERICAN MEDICAL SYSTEMS, INC.
- Product Code
- FTL
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE REGARDING THIS EVENT IT WILL BE RE-EVALUATED AND A FOLLOW-UP REPORT WILL BE SENT AS APPROPRIATE. LAWYER-FILED REPORT-(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED BY THE PLAINTIFF'S ATTORNEY THAT THE PLAINTIFF EXPERIENCED EMOTIONAL DISTRESS AND A PROBLEM WITH THE PRODUCT. RELATED TO MFR REPORT # 2183959-2013-00682. RELATED TO MFR REPORT # 2183959-2013-00684.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 64055 | MINIARC SINGLE-INCISION SLING | SURGICAL MESH | FTL | AMERICAN MEDICAL SYSTEMS, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Disability | APOGEE| ELEVATE| IMPLANTED:| IMPLANTED:| APOGEE| IMPLANTED:| ELEVATE| IMPLANTED: |