FDA Adverse Event
Death
Summary report: N
AMS SPARC SLING SYSTEM
MDR report key: 5489961
·
Received March 9, 2016
Report
- Report Number
- 3011770902-2016-00112
- Event Type
- Death
- Date Received
- March 9, 2016
- Date of Event
- February 10, 2011
- Report Date
- April 17, 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
Description of Event or Problem · 1
IT WAS REPORTED BY THE PLAINTIFF'S ATTORNEY THAT THE PLAINTIFF EXPERIENCED EROSION, RECURRENCE OF INCONTINENCE, SHARP SHOOTING PAINS, INFECTION, PAIN IN THE VAGINAL AND BLADDER AREA. THE PLAINTIFF CONTINUED TO EXPERIENCE STRESS URINARY INCONTINENCE AND THEREFORE ANOTHER MANUFACTURER'S RETROPUBIC VAGINAL SLING WAS IMPLANTED ON (B)(6) 2011. FURTHERMORE, IT WAS ALSO REPORTED THAT THE PLAINTIFF DIED. THE CAUSE OF DEATH WAS NOT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 144676 | AMS SPARC SLING SYSTEM | MESH, SURGICAL, POLYMERIC | OTN | ASTORA WOMEN'S HEALTH LLC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR | Death |