FDA Adverse Event
Injury
Summary report: N
ELEVATE POSTERIOR PROLAPSE REPAIR SYSTEM
MDR report key: 2212563
·
Received August 11, 2011
Report
- Report Number
- 2183959-2011-00293
- Event Type
- Injury
- Date Received
- August 11, 2011
- Date of Event
- July 13, 2011
- Report Date
- July 13, 2011
- Manufacturer
- AMERICAN MEDICAL SYSTEMS, INC.
- Product Code
- FTL
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- PHYSICIAN
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.
Description of Event or Problem · 1
AN ELEVATE POSTERIOR DEVICE WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT HAD "EROSION" OF THE DEVICE. ADDITIONAL INFORMATION RECEIVED INDICATES THAT ON (B)(6) 2011, THE PATIENT HAD "SIGMOIDOSCOPY MESH EXCISION AND DIVISION OF THE ELEVATE POSTERIOR MESH COMPRESSING RECTUM."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ELEVATE POSTERIOR PROLAPSE REPAIR SYSTEM | SURGICAL MESH | FTL | AMERICAN MEDICAL SYSTEMS, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |