BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BREG POST-OP SHOE

    MDR report key: 4351863 · Received December 22, 2014

    Report

    Report Number
    2028253-2014-00018
    Event Type
    Malfunction
    Date Received
    December 22, 2014
    Report Date
    December 15, 2014
    Manufacturer
    BREG, INC.
    Product Code
    IQI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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

    SOLE IS NOT ADHERING TO BASE OF SHOE. NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    842452 BREG POST-OP SHOE POST-OP SHOE IQI BREG, INC. 11192

    Patients

    Seq Age Sex Outcome Treatment
    1