MalfunctionGAS
FAST-FIX REVERSE CURVE
Received Jul 15, 2009 · Event occurred Aug 2, 2009
Report 1219602-2009-00245 · MDR key 1503164
Device
Generic name
Fast-fix Reverse Curve / Gas
Manufacturer
Mansfield Manufacturing SiteModel number
7209205Catalog number
7209205
Lot number
50283255
Product problems
- Device Slipped
- Device Issue
- Device Dislodged or Dislocated
Patient
Not reported
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
DURING A MENSICAL REPAIR, THE SUTURE CAME LOOSE AND PULLED OUT AFTER T2 WAS IMPLANTED. BOTH TS REMAIN IN THE PT. A BACK-UP DEVICE WAS AVAILABLE.
Additional Manufacturer Narrative
DEVICE IS NOT BEING RETURNED FOR EVALUATION. (B) (4)