HEELWEDGE

Description of Event or Problem

A DARCO HEELWEDGE OFF-LOADING SHOE, CAT #HQ4B FAILED WHEN THE STRAP D-SHAPED PLASTIC RING USED TO SECURE THE FOOT STRAP CAME OFF DUE TO POOR STITCHING QUALITY. THIS IS THE THIRD TIME THIS PRODUCT HAS FAILED WHILE IN USE BY ME. EACH TIME HAS CAUSED A MINOR FALL NOT REQUIRING MEDICAL ATTENTION. SINCE I HAVE GONE THROUGH 3 OF THESE SHOES OVER THE LAST 4 MONTHS WITH SIMILAR PROBLEMS. I BELIEVE THE MFR HAS A QUALITY PROBLEM IN CONSISTENT WITH FDA GMP PRACTICES. FDA SAFETY REPORT ID# (B)(4).