FDA Adverse Event
Death
Summary report: N
AMS SPARC SLING SYSTEM
MDR report key: 4920781
·
Received July 15, 2015
Report
- Report Number
- 2183959-2014-42054
- Event Type
- Death
- Date Received
- July 15, 2015
- Date of Event
- December 8, 2008
- Report Date
- June 25, 2014
- Manufacturer
- AMERICAN MEDICAL SYSTEMS, INC.
- Product Code
- OTN
- PMA / PMN Number
- K011251
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). LAWYER-FILED REPORT.
Description of Event or Problem · 1
IT WAS REPORTED BY THE PLAINTIFF'S ATTORNEY THAT THE PLAINTIFF EXPERIENCED EROSION, PAIN, EXPOSURE, RECURRENCE OF INCONTINENCE AND MULTIPLE URINARY TRACT INFECTIONS. FURTHERMORE, IT WAS REPORTED THAT THE PLAINTIFF DIED. NO CAUSE OF DEATH WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 460566 | AMS SPARC SLING SYSTEM | MESH, SURGICAL, POLYMERIC | OTN | AMERICAN MEDICAL SYSTEMS, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |