BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADJUSTAFIT BOOT

    MDR report key: 6988873 · Received October 30, 2017

    Report

    Report Number
    2028253-2017-00079
    Event Type
    Malfunction
    Date Received
    October 30, 2017
    Report Date
    October 30, 2017
    Manufacturer
    BREG, INC.
    Product Code
    IQI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT HAS BEEN RETURNED FOR EVALUATION. INVESTIGATION OF ISSUE ALREADY COMPLETED RESULTING IN A NEGLIGIBLE INCIDENCE RATE. MANUFACTURING PROCESS IMPROVEMENT ALREADY IMPLEMENTED TO PREVENT RECURRENCE.

    Description of Event or Problem · 1

    REPORTED INCIDENT OF SOLE SEPARATING FROM BOOT. NO REPORT OF INJURY INVOLVED WITH INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766287 ADJUSTAFIT BOOT ADJUSTAFIT BOOT IQI BREG, INC. AL253003

    Patients

    Seq Age Sex Outcome Treatment
    1