FDA Adverse Event
Malfunction
Summary report: N
AMS MONARC SLING SYSTEM
MDR report key: 5341626
·
Received January 4, 2016
Report
- Report Number
- 3011770902-2016-00005
- Event Type
- Malfunction
- Date Received
- January 4, 2016
- Report Date
- December 16, 2015
- Manufacturer
- ASTORA WOMEN'S HEALTH LLC
- Product Code
- OTN
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AU
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING THE IMPLANT OF A MONARC, THE PHYSICIAN HAD DIFFICULTY REMOVING THE PLASTIC SHEATH FROM THE SLING. NO PATIENT COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 417 | AMS MONARC SLING SYSTEM | MESH, SURGICAL, POLYMERIC | OTN | ASTORA WOMEN'S HEALTH LLC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |