BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BREG POST-OP SHOE

    MDR report key: 3784764 · Received May 1, 2014

    Report

    Report Number
    2028253-2014-00010
    Event Type
    Malfunction
    Date Received
    May 1, 2014
    Date of Event
    April 14, 2014
    Report Date
    May 1, 2014
    Manufacturer
    BREG, INC.
    Product Code
    IQI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVALUATION HAS CONFIRMED SEPARATION OF THE SOLE FROM THE SHOE. THE SUPPLIER OF THE POST-OP SHOE HAS BEEN ISSUED A CORRECTIVE ACTION AND HAS BEEN UNABLE TO DETERMINE THE ROOT CAUSE OF THE FAILURE. BREG IS NO LONGER DISTRIBUTING THIS PRODUCT.

    Description of Event or Problem · 1

    FRONT OF THE SHOE COMING APART ON A POST-OP SHOE AFTER 1.5 WEEKS OF USE. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261320 BREG POST-OP SHOE POST-OP SHOE IQI BREG, INC. 11193

    Patients

    Seq Age Sex Outcome Treatment
    1