BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLEDSOE

    MDR report key: 12868900 · Received November 23, 2021

    Report

    Report Number
    MW5105551
    Event Type
    Malfunction
    Date Received
    November 23, 2021
    Date of Event
    November 16, 2021
    Report Date
    November 20, 2021
    Manufacturer
    BREG, INC.
    Product Code
    ITQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    POST SURGICAL LEG BRACE, BLEDSOE REVOLUTION 3, HAD DEFECTIVE VELCRO STRAPS. STRAPS READILY DETACH, CAUSING BRACE LOOSENING SLIPPAGE, POSING ACUTE RISK OF SLIP AND FALL. BRACE TO BE WORN 6 WKS POST-SURGERY TO ALLOW FOR WOUND HEALING AND BONE SETTING. BRACE FALLING OFF DUE TO DEFECTIVE STRAPS IS AN UNACCEPTABLE RISK. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1763259 BLEDSOE JOINT, KNEE, EXTERNAL BRACE ITQ BREG, INC. G3
    1763261 BLEDSOE JOINT, KNEE, EXTERNAL BRACE ITQ BREG, INC. G3 UNK
    1763262 BLEDSOE JOINT, KNEE, EXTERNAL BRACE ITQ BREG, INC. G3

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male Other