FDA Adverse Event
Death
Summary report: N
AMS PERIGEE SYSTEM WITH INTEPRO
MDR report key: 5021016
·
Received August 21, 2015
Report
- Report Number
- 2183959-2015-57245
- Event Type
- Death
- Date Received
- August 21, 2015
- Date of Event
- December 13, 2007
- Report Date
- August 4, 2015
- Manufacturer
- AMERICAN MEDICAL SYSTEMS, INC.
- Product Code
- OTP
- PMA / PMN Number
- K082387
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- ATTORNEY
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 EXPERIENCED RECTOCELE, ENTEROCELE, PERINEAL GAPING, EXPOSED MESH AND VAGINAL ATROPHY. IT WAS ALSO REPORTED THAT THE PLAINTIFF ALLEGEDLY EXPERIENCED PAIN, INFECTIONS AND INCONTINENCE. FURTHERMORE, IT WAS REPORTED THAT THE PLAINTIFF DIED. NO CAUSE OF DEATH WAS REPORTED. RELATED TO MANUFACTURER REPORT #: 2183959-2015-57258.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 553978 | AMS PERIGEE SYSTEM WITH INTEPRO | MESH, SURGICAL, POLYMERIC | OTP | AMERICAN MEDICAL SYSTEMS, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Death | MONARC |