BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REBOUND AIR WALKER

    MDR report key: 19088731 · Received April 10, 2024

    Report

    Report Number
    MW5153728
    Event Type
    Injury
    Date Received
    April 10, 2024
    Date of Event
    April 7, 2024
    Report Date
    April 8, 2024
    Manufacturer
    OSSUR AMERICAS
    Product Code
    ITW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I WAS TIGHTENING A MEDICAL BOOT DEVICE THAT MY DOCTOR PROVIDED TO HELP WITH MY RECOVERY FROM A SEVERE LEG/ANKLE INJURY. IT IS A OSSUR REBOUND AIR WALKER. WHEN TIGHTENING THE STRAP FOR THE CRITICAL ANKLE AREA, THE LOOP THAT THE VELCRO STRAP GOES THROUGH DISCONNECTED FROM THE BOOT. THUS NOT ALLOWING ME TO SECURE MY FOOT INTO THE BOOT. MY FOOT WAS NOW IN AN UNSTABLE ENVIRONMENT, I HAD TO REMOVE THE BOOT AND MAINTAIN NO WEIGHT ON THE FOOT TO PREVENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    808776 REBOUND AIR WALKER JOINT, ANKLE, EXTERNAL BRACE ITW OSSUR AMERICAS

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male Required Intervention