BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TILITE AERO X

    MDR report key: 4059558 · Received August 14, 2014

    Report

    Report Number
    3032618-2014-00003
    Event Type
    Malfunction
    Date Received
    August 14, 2014
    Date of Event
    July 16, 2014
    Report Date
    August 14, 2014
    Manufacturer
    TISPORT, LLC
    Product Code
    IOR
    PMA / PMN Number
    K072311
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PROVIDER SAYS THE FOOTPLATE CLAMP WAS NOT HOLDING PROPERLY AND WAS CAUSING IT TO ROTATE TOWARDS THE GROUND WHICH CAUSED THE USERS HEELS TO DRAG ON THE GROUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    487302 TILITE AERO X WHEEL CHAIR, MECHANICAL IOR TISPORT, LLC AERO X

    Patients

    Seq Age Sex Outcome Treatment
    1