FDA Adverse Event
Death
Summary report: N
AMS PERIGEE SYSTEM WITH INTEPRO
MDR report key: 4973342
·
Received August 5, 2015
Report
- Report Number
- 2183959-2014-13652
- Event Type
- Death
- Date Received
- August 5, 2015
- Date of Event
- January 3, 2006
- Report Date
- February 14, 2014
- Manufacturer
- AMERICAN MEDICAL SYSTEMS, INC.
- Product Code
- OTP
- PMA / PMN Number
- K082387
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- ATTORNEY
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 EXPERIENCED LOWER BACK PAIN, URINARY TRACT INFECTION, URINARY RETENTION, OVERFLOW INCONTINENCE, DYSURIA, BURNING, HEMATURIA, BLEEDING, AND UNABLE TO VOID. IT WAS ALSO REPORTED THAT THE PLAINTIFF ALLEGEDLY EXPERIENCED AN EMOTIONAL DISTRESS, INFECTION, BOWEL PROBLEMS, RECURRENCE, OTHER UNSPECIFIED INJURY, AND A PRODUCT PROBLEM. FURTHERMORE, IT WAS REPORTED THAT THE PLAINTIFF DIED. THE CAUSE OF DEATH REPORTED WERE HYPOXIA, PULMONARY EDEMA, PNEUMONIA, AND BREAST CANCER. RELATED TO MANUFACTURER REPORT #: 2183959-2014-13653.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 513381 | AMS PERIGEE SYSTEM WITH INTEPRO | MESH, SURGICAL, POLYMERIC | OTP | AMERICAN MEDICAL SYSTEMS, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR | Death | MONARC| MONARC |