FDA Adverse Event
Death
Summary report: N
AMS MONARC SLING SYSTEM
MDR report key: 4908124
·
Received July 9, 2015
Report
- Report Number
- 2183959-2014-22491
- Event Type
- Death
- Date Received
- July 9, 2015
- Date of Event
- February 3, 2011
- Report Date
- April 10, 2014
- 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
(B)(4). LAWYER-FILED REPORT.
Description of Event or Problem · 1
IT WAS REPORTED BY THE PLAINTIFF'S ATTORNEY THAT THE PLAINTIFF ALLEGEDLY EXPERIENCED PAIN AND INFECTIONS. IT WAS ALSO REPORTED THAT THE PLAINTIFF EXPERIENCED PERSISTENT URINARY INCONTINENCE, REFRACTORY URINARY RETENTION AND URETEROLYSIS. FURTHERMORE, IT WAS REPORTED THAT THE PLAINTIFF DIED. NO CAUSE OF DEATH WAS REPORTED. RELATED TO MANUFACTURER REPORT #: 2183959-2014-22447.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 446114 | AMS MONARC SLING SYSTEM | MESH, SURGICAL, POLYMERIC | OTN | AMERICAN MEDICAL SYSTEMS, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Death | SPARC | SPARC |