FDA Adverse Event
Death
Summary report: N
AMS INTEPRO Y-MESH
MDR report key: 3910010
·
Received June 11, 2014
Report
- Report Number
- 2183959-2014-28928
- Event Type
- Death
- Date Received
- June 11, 2014
- Report Date
- May 13, 2014
- Manufacturer
- AMERICAN MEDICAL SYSTEMS, INC.
- Product Code
- OTP
- PMA / PMN Number
- K033636
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MS, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
LAWYER-FILED REPORT.
Description of Event or Problem · 1
IT WAS REPORTED BY THE PLAINTIFF'S ATTORNEY THAT THE PLAINTIFF EXPERIENCED EMOTIONAL DISTRESS AND A PRODUCT PROBLEM. IT WAS ADDITIONALLY REPORTED THE PLAINTIFF DIED, NO CAUSE OF DEATH WAS REPORTED. RELATED TO MANUFACTURER REPORT #2123959-2014-28826, 28938.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 346178 | AMS INTEPRO Y-MESH | MESH, SURGICAL, POLYMERIC | OTP | AMERICAN MEDICAL SYSTEMS, INC. | 451609 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death | MONARC| PERIGEE SYSTEM WITH INTEPRO LITE |