FDA Adverse Event
Death
Summary report: N
AMS ELEVATE POSTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE
MDR report key: 5452390
·
Received February 22, 2016
Report
- Report Number
- 3011770902-2016-00083
- Event Type
- Death
- Date Received
- February 22, 2016
- Report Date
- May 2, 2014
- Manufacturer
- ASTORA WOMEN'S HEALTH LLC
- Product Code
- OTP
- 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 CHRONIC PAIN, BLEEDING, LOWER ABDOMINAL PAIN, BOWEL PROBLEMS, PAINFUL INTERCOURSE, FISTULAS, NEUROMUSCULAR PROBLEMS, EMOTIONAL/PSYCHOLOGICAL CONDITIONS. FURTHERMORE, IT WAS REPORTED THAT THE PLAINTIFF DIED. NO CAUSE OF DEATH WAS REPORTED. RELATED TO MFR#: 3011770902-2016-00081, 3011770902-2016-00082.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 107828 | AMS ELEVATE POSTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE | SURGICAL MESH | OTP | ASTORA WOMEN'S HEALTH LLC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death | MONARC| PERIGEE |