FDA Adverse Event
Death
Summary report: N
AMS PERIGEE SYSTEM
MDR report key: 4897916
·
Received July 6, 2015
Report
- Report Number
- 2183959-2014-55264
- Event Type
- Death
- Date Received
- July 6, 2015
- Date of Event
- July 22, 2009
- Report Date
- August 14, 2014
- Manufacturer
- AMERICAN MEDICAL SYSTEMS, INC.
- Product Code
- OTP
- PMA / PMN Number
- K040623
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THIS WAS INITIALLY SUBMITTED ON THE SUMMARY REPORT DATED (B)(6), 2014 UNDER (B)(4). LAWYER-FILED REPORT.
Description of Event or Problem · 1
IT WAS REPORTED BY THE PLAINTIFF'S ATTORNEY THAT THE PLAINTIFF EXPERIENCED MESH EROSION, RECTOCELE, BOWEL DYSFUNCTION, CHRONIC CONSTIPATION, ATROPHIC VAGINITIS AND EXTRUSION. IT WAS ALSO REPORTED THAT THE PLAINTIFF ALLEGEDLY EXPERIENCED URINARY INCONTINENCE, INCOMPLETE BLADDER EMPTYING, URGE LEAKAGE, RECURRING URINARY TRACT INFECTIONS, LOWER ABDOMINAL PAIN, DYSURIA AND VAGINAL BLEEDING. FURTHERMORE, IT WAS REPORTED THAT THE PLAINTIFF DIED. NO CAUSE OF DEATH WAS REPORTED. RELATED TO MFR REPORT # 219395-2014-55919.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 434891 | AMS PERIGEE SYSTEM | MESH, SURGICAL, POLYMERIC | OTP | AMERICAN MEDICAL SYSTEMS, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Death | MONARC| MONARC |