FDA Adverse Event
Death
Summary report: N
AMS MONARC SLING SYSTEM
MDR report key: 5452303
·
Received February 22, 2016
Report
- Report Number
- 3011770902-2016-00076
- Event Type
- Death
- Date Received
- February 22, 2016
- Date of Event
- June 12, 2012
- Report Date
- January 2, 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 Location
- US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
THIS WAS INITIALLY REPORTED ON THE SUMMARY REPORT DATED 10/31/2014 UNDER EXEMPTION E2013032
Description of Event or Problem · 0
IT WAS REPORTED BY THE PLAINTIFF'S ATTORNEY THAT THE PLAINTIFF ALLEGEDLY EXPERIENCED PAIN, EROSION, INFECTION, URINARY PROBLEMS, DYSPAREUNIA, RECURRENCE, EMOTIONAL DISTRESS AND PRODUCT PROBLEM. IT WAS ALSO REPORTED THAT THE PLAINTIFF EXPERIENCED CYSTOURETHROCELE, STRESS URINARY INCONTINENCE, AND CHRONIC INFLAMED BLADDER MUCOSA. IT WAS ALSO REPORTED THAT THE PLAINTIFF UNDERWENT 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 |
|---|---|---|---|---|---|---|---|
| 107932 | AMS MONARC SLING SYSTEM | MESH, SURGICAL, POLYMERIC | OTN | ASTORA WOMEN'S HEALTH LLC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR | Death |