FDA Adverse Event
Death
Summary report: N
AMS SPARC SLING SYSTEM
MDR report key: 5452391
·
Received February 22, 2016
Report
- Report Number
- 3011770902-2016-00079
- Event Type
- Death
- Date Received
- February 22, 2016
- Date of Event
- April 8, 2008
- Report Date
- March 29, 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 6/30/2014 UNDER EXEMPTION E2013032.
Description of Event or Problem · 0
IT WAS REPORTED BY THE PLAINTIFF'S ATTORNEY THAT THE PLAINTIFF EXPERIENCED MIXED URINARY INCONTINENCE, FREQUENCY, OVERACTIVE BLADDER, ATROPHIC VAGINITIS, INABILITY TO URINATE, INTERMITTENT DYSURIA, BLADDER PAIN, MILD URETHRAL TENDERNESS, EROSION OF SYNTHETIC SLING, VISIBLE MESH IN THE BLADDER, CALCIUM DEPOSIT AT THE BLADDER NECK, BLADDER CALCULI, RECURRENT URINARY TRACT INFECTIONS, AND URETHRITIS. ON (B)(6) 2008, THE PLAINTIFF UNDERWENT A REVISION SURGERY. 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 |
|---|---|---|---|---|---|---|---|
| 108689 | AMS SPARC SLING SYSTEM | MESH, SURGICAL, POLYMERIC | OTN | ASTORA WOMEN'S HEALTH LLC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 93 YR | Death |