BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BREG POST-OP SHOE

    MDR report key: 2874496 · Received December 14, 2012

    Report

    Report Number
    2028253-2012-00028
    Event Type
    Malfunction
    Date Received
    December 14, 2012
    Date of Event
    November 5, 2012
    Report Date
    December 14, 2012
    Manufacturer
    BREG, INC.
    Product Code
    IPG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BREG POST-OP SHOE POST-OP SHOE IPG BREG, INC. 1118L

    Patients

    Seq Age Sex Outcome Treatment
    1 53 Required Intervention