FDA Adverse Event
Death
Summary report: N
AMS APOGEE SYSTEM WITH PC COATED INTEPRO LITE
MDR report key: 4192815
·
Received October 20, 2014
Report
- Report Number
- 2183959-2014-46252
- Event Type
- Death
- Date Received
- October 20, 2014
- Report Date
- April 5, 2013
- Manufacturer
- AMERICAN MEDICAL SYSTEMS, INC.
- Product Code
- OTP
- PMA / PMN Number
- K081710
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- 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, EROSION, EXTRUSION, INFECTION, URINARY PROBLEMS, RECURRENCE, ORGAN PERFORATION, EMOTIONAL DISTRESS, AND A PRODUCT PROBLEM. FURTHERMORE, IT WAS REPORTED THAT THE PLAINTIFF DIED. THE CAUSE OF DEATH WAS REPORTED AS RENAL FAILURE. RELATED TO MANUFACTURER REPORT #2183959-2014-46248, #2183959-2014-56807.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 666789 | AMS APOGEE SYSTEM WITH PC COATED INTEPRO LITE | MESH, SURGICAL, POLYMERIC | OTP | AMERICAN MEDICAL SYSTEMS, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death | PERIGEE| MONARC |