FDA Adverse Event
Death
Summary report: N
AMS MINIARC SLING SYSTEM
MDR report key: 4990142
·
Received August 11, 2015
Report
- Report Number
- 2183959-2015-56933
- Event Type
- Death
- Date Received
- August 11, 2015
- Date of Event
- March 7, 2011
- Report Date
- July 20, 2015
- Manufacturer
- AMERICAN MEDICAL SYSTEMS, INC.
- Product Code
- PAH
- PMA / PMN Number
- K071902
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- ATTORNEY
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 URINARY AND RECTAL INCONTINENCE AND URINARY TRACT INFECTION. FURTHERMORE, IT WAS REPORTED THAT THE PLAINTIFF DIED. THE CAUSES OF DEATH REPORTED WERE CEREBROVASCULAR ACCIDENT AND DIABETES MELLITUS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 527336 | AMS MINIARC SLING SYSTEM | MESH, SURGICAL, POLYMERIC | PAH | AMERICAN MEDICAL SYSTEMS, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Death |