FDA Adverse Event
Injury
Summary report: N
MONARC SLING SYSTEM
MDR report key: 2181306
·
Received July 21, 2011
Report
- Report Number
- 2183959-2011-00268
- Event Type
- Injury
- Date Received
- July 21, 2011
- Date of Event
- June 22, 2011
- Report Date
- June 22, 2011
- Manufacturer
- AMERICAN MEDICAL SYSTEMS, INC.
- Product Code
- FTL
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE REGARDING THIS EVENT, IT WILL BE RE-EVALUATED AND A FOLLOW-UP REPORT WILL BE SENT.
Description of Event or Problem · 1
IT WAS REPORTED THAT A MONARC DEVICE WAS IMPLANTED. AMS HAS BEEN INFORMED THAT A LEGAL CLAIM IS PENDING; NO FURTHER INFORMATION HAS BEEN PROVIDED TO-DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MONARC SLING SYSTEM | SURGICAL MESH | FTL | AMERICAN MEDICAL SYSTEMS, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Disability |