BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICKIE

    MDR report key: 1062572 · Received June 20, 2008

    Report

    Report Number
    2937137-2008-00009
    Event Type
    Injury
    Date Received
    June 20, 2008
    Date of Event
    June 12, 2008
    Report Date
    June 20, 2008
    Manufacturer
    SUNRISE MEDICAL
    Product Code
    IOR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SALES REP DID A PHYSICAL INSPECTION OF THIS CHAIR AND FOUND THAT THE PINS FOR THE SHORT SECTION OF THE ANTI-TIPS WERE NOT ENGAGED WHICH COULD CAUSE THE CHAIR LIKELY TO TIP BACK. THE TIPS WOULD PUSH UP OVER THE TUBE SHORTENING THE ANTI-TIPS ABOUT 3 INCHES WHEN THESE PINS ARE NOT ENGAGED. THERE WAS NO PRODUCT DAMAGE OR MALFUNCTION.

    Description of Event or Problem · 1

    THE REPORTER STATED THAT THE END-USER WAS TRYING OUT A DEMO, CHAIR, WHILE GOING UP A RAMP ONTO A DECK IN BACK OF HIS HOUSE. THE CHAIR TIPPED BACKWARDS OVER THE REAR ANTI-TIPS CAUSING THE END-USER TO FALL BACKWARDS. THE END-USER DID SEEK MEDICAL ATTENTION AND HE DID RECEIVED A BLOOD CLOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUICKIE WHEELCHAIR, MECHANICAL IOR SUNRISE MEDICAL QUICKIE 2 P/N EIQ2

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization