FDA Adverse Event
Death
Summary report: N
AMS MONARC SLING SYSTEM
MDR report key: 5514216
·
Received March 21, 2016
Report
- Report Number
- 3011770902-2016-00125
- Event Type
- Death
- Date Received
- March 21, 2016
- Date of Event
- May 10, 2012
- Report Date
- March 16, 2016
- Manufacturer
- ASTORA WOMEN'S HEALTH LLC
- Product Code
- OTN
- PMA / PMN Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED BY THE PLAINTIFF'S ATTORNEY THAT THE PLAINTIFF ALLEGEDLY EXPERIENCED PAIN, INFECTION, RECURRENCE, BLEEDING, ADHESIONS, TUMOR, EMOTIONAL DISTRESS, AND A PRODUCT PROBLEM. IT WAS ALSO REPORTED THAT THE PLAINTIFF EXPERIENCED STRESS AND URGE URINARY INCONTINENCE, BLADDER DEFORMITY, SCARRING, MESH EROSION, INTRINSIC URETHRAL SPHINCTER DEFICIENCY, URINARY RETENTION, SLOW STREAM VOIDING, RIGHT OVARIAN MASS, CHRONIC HEMATOMA, AND LYMPHOCELE. FURTHERMORE, THE PLAINTIFF DIED. THE CAUSES OF DEATH WERE REPORTED AS RESPIRATORY FAILURE, ASPIRATION PNEUMONIA, AND RENAL CELL CARCINOMA. RELATED TO MFR # 3011770902-2016-00124.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 170443 | AMS MONARC SLING SYSTEM | MESH, SURGICAL, POLYMERIC | OTN | ASTORA WOMEN'S HEALTH LLC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR | Death | MINIARC PRECISE |