FDA Adverse Event
Death
Summary report: N
AMS SPARC SLING SYSTEM
MDR report key: 5489957
·
Received March 9, 2016
Report
- Report Number
- 3011770902-2016-00111
- Event Type
- Death
- Date Received
- March 9, 2016
- Report Date
- May 2, 2014
- Manufacturer
- ASTORA WOMEN'S HEALTH LLC
- Product Code
- OTN
- PMA / PMN Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
THIS WAS INITIALLY REPORTED ON THE SUMMARY REPORT DATED 8/30/2014 UNDER EXEMPTION E2013032.
Description of Event or Problem · 0
IT WAS REPORTED BY THE PLAINTIFF'S ATTORNEY THAT THE PLAINTIFF EXPERIENCED RECURRENCES OF THE ORIGINAL PROBLEMS, BOWEL PROBLEMS, AND URINARY 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 |
|---|---|---|---|---|---|---|---|
| 144675 | AMS SPARC SLING SYSTEM | MESH, SURGICAL, POLYMERIC | OTN | ASTORA WOMEN'S HEALTH LLC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death | SURGISIS |