FDA Adverse Event
Death
Summary report: N
AMS MONARC SLING SYSTEM
MDR report key: 4934432
·
Received July 21, 2015
Report
- Report Number
- 2183959-2014-44593
- Event Type
- Death
- Date Received
- July 21, 2015
- Date of Event
- June 2, 2014
- Report Date
- June 12, 2014
- Manufacturer
- AMERICAN MEDICAL SYSTEMS, INC.
- Product Code
- OTN
- PMA / PMN Number
- K023516
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THIS WAS INITIALLY REPORTED ON THE SUMMARY REPORT DATED (B)(6) 2014 UNDER EXEMPTION (B)(4). LAWYER-FILED REPORT.
Description of Event or Problem · 1
ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE CAUSE OF DEATH WERE REPORTED AS CARDIOPULMONARY ARREST WITH ANOXIC BRAIN INJURY, ACUTE HYPOXIC RESPIRATORY FAILURE AND ASTHMA EXACERBATION.
Description of Event or Problem · 1
IT WAS REPORTED BY THE PLAINTIFF'S ATTORNEY THAT THE PLAINTIFF'S ATTORNEY THAT THE PLAINTIFF EXPERIENCED CHRONIC VAGINAL PAIN. FURTHERMORE, IT WAS REPORTED THAT THE PLAINTIFF DIED. NO CAUSE OF DEATH WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 470796 | AMS MONARC SLING SYSTEM | MESH, SURGICAL, POLYMERIC | OTN | AMERICAN MEDICAL SYSTEMS, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Death |