BREG POST-OP SHOE
Received Dec 14, 2012 · Event occurred Nov 5, 2012
Report 2028253-2012-00028 · MDR key 2874496
Device
Product problems
- Break
Patient
53
- Fall
- Bone Fracture(s)
- Injury
Narrative
Description of Event or Problem
ON (B)(4) 2012, BREG, INC RECEIVED NOTICE FROM AN ATTORNEY THAT A PATIENT (HIS CLIENT) WHO WAS USING THE BREG POST-OP SHOE ALLEGES TO HAVE FALLEN AND INJURED HERSELF WHEN THE SOLE OF THE POST-OP SHOE BROKE AWAY FROM THE MAIN BODY OF THE SHOE. THE PATIENT HAD WART SURGERY ON HER RIGHT HEEL ON (B)(6) 2012 AND WAS GIVEN A BREG POST-OP SHOE AFTER THE SURGERY. ON (B)(6) 2012, THE PATIENT WAS SITTING IN HER KITCHEN AND WHEN SHE ATTEMPTED TO STAND UP, SHE ASSERTS THAT THE POST-OP SHOE SEPARATED AND THE SOLE CAME APART FROM THE BODY OF THE SHOE. THE PATIENT CLAIMS THAT SHE THEN FELL TO THE GROUND FRACTURING HER OPPOSITE LEFT ANKLE. THE PATIENT SOUGHT MEDICAL ATTENTION AT (B)(6) HOSPITAL WHERE AN X-RAY CONFIRMED THAT HER ANKLE WAS FRACTURED. THE PATIENT'S ATTORNEY INDICATED THAT THE SHOE WOULD NOT BE RETURNED FOR EVALUATION BY BREG BUT HE HAS PROVIDED PICTURES OF THE SHOE.
Additional Manufacturer Narrative
DEVICE NOT RETURNED FOR EVALUATION.