FDA Adverse Event
Death
Summary report: N
AMS MONARC SLING SYSTEM
MDR report key: 5536256
·
Received March 30, 2016
Report
- Report Number
- 3011770902-2016-00142
- Event Type
- Death
- Date Received
- March 30, 2016
- Date of Event
- May 23, 2011
- Report Date
- April 4, 2014
- 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
Additional Manufacturer Narrative · 0
THIS WAS INITIALLY REPORTED ON THE SUMMARY REPORT DATED 6/30/2014 UNDER EXEMPTION E2013032
Description of Event or Problem · 0
IT WAS REPORTED BY THE PLAINTIFF'S ATTORNEY THAT THE PLAINTIFF ALLEGEDLY EXPERIENCED EMOTIONAL DISTRESS AND A PRODUCT PROBLEM. THE PLAINTIFF ALSO EXPERIENCED STAGE 3 PELVIC ORGAN PROLAPSE, STRESS URINARY INCONTINENCE, STAGE 1 CYSTOCELE AND STAGE 1 RECTOCELE. FURTHERMORE, IT WAS REPORTED THAT THE PLAINTIFF DIED. THE CAUSES OF DEATH WERE REPORTED AS RESPIRATORY FAILURE, HEART FAILURE, CHRONIC OBSTRUCTIVE PULMONARY DISEASE, ISCHEMIC HEART DISEASE AND ASTHMA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 190733 | AMS MONARC SLING SYSTEM | MESH, SURGICAL, POLYMERIC | OTN | ASTORA WOMEN'S HEALTH LLC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Death |