FDA Adverse Event
Injury
Summary report: N
ELEVATE PROLAPSE REPAIR SYSTEM
MDR report key: 2926305
·
Received January 16, 2013
Report
- Report Number
- 2183959-2013-00237
- Event Type
- Injury
- Date Received
- January 16, 2013
- Report Date
- December 5, 2012
- Manufacturer
- AMERICAN MEDICAL SYSTEMS, INC.
- Product Code
- OTP
- 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. 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. THE DEVICE WAS IMPLANTED FOR TREATMENT. RELATED MFR REPORT #: 2183959-2013-00236 AND 2183959-2013-00239.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 23386 | ELEVATE PROLAPSE REPAIR SYSTEM | SURGICAL MESH | OTP | AMERICAN MEDICAL SYSTEMS, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Disability | IMPLANT DATE:| IMPLANT DATE:| IMPLANT DATE:| MINIARC| MINIARC| OBTRYX| OBTRYX| MINIARC| IMPLANT DATE:| IMPLANT DATE:| MINIARC| IMPLANT DATE: |