BEUDAMED
    FDA Adverse Event Other Summary report: N

    QUICKIE

    MDR report key: 1696679 · Received May 18, 2010

    Report

    Report Number
    2937137-2010-00006
    Event Type
    Other
    Date Received
    May 18, 2010
    Date of Event
    August 14, 2009
    Report Date
    May 14, 2010
    Manufacturer
    SUNRISE MEDICAL, INC.
    Product Code
    IOR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MFR HAS NOT RECEIVED ENOUGH INFO TO MAKE ANY CONCLUSIONS AT THIS TIME. PRODUCT HAS NOT BEEN RETURNED TO MFR FOR EVAL. IT IS NOT KNOWN IF THE INJURIES SUSTAINED BY USER ARE SERIOUS OR REQUIRED MEDICAL INTERVENTION AT THIS TIME NOR IF THE PRODUCT MALFUNCTIONED OR NOT BEING USED AS INTENDED. WHEN INVESTIGATION IS COMPLETE, A F/U REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    REPORTER STATED THAT WHILE USER WAS ON EMBANKMENT, WHEEL LOCKS DISENGAGED RESULTING IN USER GOING DOWN EMBANKMENT ONTO RAILROAD TRACKS. USER SUSTAINED INJURIES TO HIS FACE; BUMPS AND BRUISING. UNK AT THIS TIME IF, OR WHAT TYPE OF MEDICAL ATTENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUICKIE WHEELCHAIR, MECHANICAL IOR SUNRISE MEDICAL, INC. QUICKIE IRIS EIZ4

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK