FDA Adverse Event
Malfunction
Summary report: N
GMD UNIVERSAL SLING
MDR report key: 1627518
·
Received February 16, 2010
Report
- Report Number
- 3006142121-2009-00020
- Event Type
- Malfunction
- Date Received
- February 16, 2010
- Date of Event
- January 7, 2010
- Report Date
- February 15, 2010
- Manufacturer
- GENERIC MEDICAL DEVICE, INC.
- Product Code
- FTL
- PMA / PMN Number
- K083471
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EVALUATION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. INVESTIGATION IS IN PROCESS. WHEN MORE INFO IS AVAILABLE A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED.
Description of Event or Problem · 1
DURING SLING PLACEMENT ON RIGHT SIDE SLEEVE BROKE OFF AT SLING BOND POSITION. DAMAGED SLING WAS REMOVED AND REPLACED WITH A SECOND GMD SLING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GMD UNIVERSAL SLING | FTL-SURGICAL MESH | FTL | GENERIC MEDICAL DEVICE, INC. | 1010-12 | 21819 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |