BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICKIE 2 LITE

    MDR report key: 1908918 · Received November 20, 2010

    Report

    Report Number
    MW5018294
    Event Type
    Injury
    Date Received
    November 20, 2010
    Date of Event
    September 20, 2010
    Report Date
    November 20, 2010
    Manufacturer
    SUNRISE MEDICAL
    Product Code
    IOR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    QUICKIE 2 MANUAL FOLDING WHEELCHAIR - 6 MONTHS OLD - 3-BOLT MALFUNCTIONS, CASTER BOLT ASSEMBLY MALFUNCTIONS. ONE BOLT CAME LOOSE CAUSING SEVERE WOBBLE - ALL BOLTS ON BOTH SIDES TIGHTENED. ONE WEEK LATER WHOLE CASTER ASSEMBLY TILTED AS THE RESULT OF BOTTOM BOLT COMING COMPLETELY OUT CAUSING: CHAIR TO TILT AND USER FALL, SUSTAINING INJURIES. ONE MONTH LATER, BOLT HOLDING WHEELCHAIR HANDLE TO FRAME FELL OUT CAUSING POTENTIAL HAZARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUICKIE 2 LITE NONE IOR SUNRISE MEDICAL QUICKIE 2 LITE

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other