FDA Adverse Event
Death
Summary report: N
AMS MONARC SLING SYSTEM
MDR report key: 5353367
·
Received January 8, 2016
Report
- Report Number
- 2183959-2016-00010
- Event Type
- Death
- Date Received
- January 8, 2016
- Date of Event
- March 8, 2007
- Report Date
- December 30, 2015
- 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
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE CAUSE OF DEATH WAS REPORTED AS RENAL FAILURE.
Description of Event or Problem · 1
IT WAS REPORTED BY THE PLAINTIFF'S ATTORNEY THAT THE PLAINTIFF EXPERIENCED URGENCY, FREQUENCY, AND INTERSTITIAL CYSTITIS. IT WAS ALSO REPORTED THAT THE PLAINTIFF ALLEGEDLY EXPERIENCED URINARY PROBLEMS, LEAKAGE, RECURRENT AND PERSISTENT URINARY TRACT INFECTIONS, AND PELVIC PAIN. 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 |
|---|---|---|---|---|---|---|---|
| 13874 | AMS MONARC SLING SYSTEM | MESH, SURGICAL, POLYMERIC | OTN | ASTORA WOMEN'S HEALTH LLC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Death |