FDA Adverse Event
Death
Summary report: N
AMS MINIARC SLING SYSTEM
MDR report key: 5522675
·
Received March 24, 2016
Report
- Report Number
- 3011770902-2016-00130
- Event Type
- Death
- Date Received
- March 24, 2016
- Report Date
- August 20, 2013
- Manufacturer
- ASTORA WOMEN'S HEALTH LLC
- Product Code
- PAH
- 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 JUNE 30, 2014 UNDER EXEMPTION E2013032
Description of Event or Problem · 0
IT WAS REPORTED BY THE PLAINTIFF'S ATTORNEY THAT THE PLAINTIFF ALLEGEDLY EXPERIENCED EMOTIONAL DISTRESS AND A PRODUCT PROBLEM. FURTHERMORE, IT WAS REPORTED THAT THE PLAINTIFF DIED. THE CAUSES OF DEATH WERE REPORTED AS MESENTERIC THROMBUS AND CARDIAC ARREST.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 179322 | AMS MINIARC SLING SYSTEM | MESH, SURGICAL, POLYMERIC | PAH | ASTORA WOMEN'S HEALTH LLC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |