FDA Adverse Event
Death
Summary report: N
AMS SPARC SLING SYSTEM
MDR report key: 5536371
·
Received March 30, 2016
Report
- Report Number
- 3011770902-2016-00145
- Event Type
- Death
- Date Received
- March 30, 2016
- Date of Event
- September 23, 2009
- Report Date
- August 6, 2013
- Manufacturer
- ASTORA WOMEN'S HEALTH LLC
- Product Code
- OTN
- PMA / PMN Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- 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 ALLEGEDLY EXPERIENCED PAIN, EROSION, DYSPAREUNIA, URINARY PROBLEMS, RECURRENCE OF INCONTINENCE AND EMOTIONAL DISTRESS. THE PLAINTIFF UNDERWENT A REMOVAL SURGERY AND THE MESH WAS PARTIALLY EXPLANTED. IT WAS ALSO REPORTED THAT THE PLAINTIFF EXPERIENCED VAGINAL BLEEDING, MILD CYSTOCELE, CHRONIC INFLAMMATION AND EXTRUSION. FURTHERMORE, IT WAS REPORTED THAT THE PLAINTIFF DIED. NO CAUSE OF DEATH WAS REPORTED. RELATED TO MFR# 3011770902-2016-00143 AND 3011770902-2016-00144.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 191424 | AMS SPARC SLING SYSTEM | MESH, SURGICAL, POLYMERIC | OTN | ASTORA WOMEN'S HEALTH LLC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Death | APOGEE| PERIGEE |