FDA Adverse Event
Injury
Summary report: N
ELEVATE ANTERIOR PROLAPSE REPAIR SYSTEM
MDR report key: 2932139
·
Received January 25, 2013
Report
- Report Number
- 2183959-2013-00460
- Event Type
- Injury
- Date Received
- January 25, 2013
- Report Date
- December 13, 2012
- Manufacturer
- AMERICAN MEDICAL SYSTEMS, INC.
- Product Code
- OTP
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, 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). THE REPORTER INDICATED "PARTIAL USE" OF TWO ELEVATE ANTERIOR PROLAPSE REPAIR SYSTEMS. IT APPEARS THE DEVICE WITH SERIAL # (B)(4), MFR DATE 12/01/2010, EXPIRATION DATE 12/07/2013, WAS IMPLANTED AND OTHER COMPONENTS OF SERIAL # (B)(4), MFR DATE 09/01/2010, EXPIRATION DATE 09/29/2013, WERE USED.
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 #: 2183959-2013-00443 AND 2183959-2013-00442.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 36285 | ELEVATE ANTERIOR PROLAPSE REPAIR SYSTEM | SURGICAL MESH | OTP | AMERICAN MEDICAL SYSTEMS, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Disability | ELEVATE| IMPLANT DATE:| IMPLANT DATE:| MINIARC| MINIARC| ELEVATE| IMPLANT DATE:| IMPLANT DATE: |