FDA Adverse Event
Death
Summary report: N
AMS MONARC SLING SYSTEM
MDR report key: 4934433
·
Received July 21, 2015
Report
- Report Number
- 2183959-2015-55067
- Event Type
- Death
- Date Received
- July 21, 2015
- Date of Event
- September 7, 2010
- Report Date
- June 30, 2015
- Manufacturer
- AMERICAN MEDICAL SYSTEMS, INC.
- Product Code
- OTN
- PMA / PMN Number
- K023516
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
LAWYER-FILED REPORT.
Description of Event or Problem · 1
IT WAS REPORTED BY THE PLAINTIFF'S ATTORNEY THAT THE PLAINTIFF ALLEGEDLY EXPERIENCED PAIN AND RECURRENCE OF STRESS URINARY INCONTINENCE. FURTHERMORE, IT WAS REPORTED THAT THE PLAINTIFF DIED. NO CAUSE OF DEATH WAS REPORTED. RELATED TO MANUFACTURER REPORT #: 2183959-2015-55065. RELATED TO MANUFACTURER REPORT #: 2183959-2015-55066.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 471450 | AMS MONARC SLING SYSTEM | MESH, SURGICAL, POLYMERIC | OTN | AMERICAN MEDICAL SYSTEMS, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Death | INTEXEN| INTEXEN |