FDA Adverse Event
Death
Summary report: N
AMS MONARC SLING SYSTEM
MDR report key: 4908117
·
Received July 9, 2015
Report
- Report Number
- 2183959-2015-54363
- Event Type
- Death
- Date Received
- July 9, 2015
- Date of Event
- April 11, 2012
- Report Date
- June 22, 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. IT WAS ALSO REPORTED THAT THE PLAINTIFF EXPERIENCED TOTAL VAGINAL PROLAPSE, ENTEROCELE AND CYSTOCELE. FURTHERMORE, IT WAS REPORTED THAT THE PLAINTIFF DIED. NO CAUSE OF DEATH WAS REPORTED. RELATED TO MANUFACTURER REPORT #: 2183959-2014-11949. RELATED TO MANUFACTURER REPORT #: 2183959-2014-12020. RELATED TO MANUFACTURER REPORT #: 2183959-2014-12025. RELATED TO MANUFACTURER REPORT #: 2183959-2014-45771.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 447963 | AMS MONARC SLING SYSTEM | MESH, SURGICAL, POLYMERIC | OTN | AMERICAN MEDICAL SYSTEMS, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Death | INTEXEN| SPARC| ELEVATE ANTERIOR AND INTEXEN |