BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICKIE 2 LITE

    MDR report key: 3204762 · Received June 27, 2013

    Report

    Report Number
    2937137-2013-00015
    Event Type
    Injury
    Date Received
    June 27, 2013
    Date of Event
    May 30, 2013
    Report Date
    May 30, 2013
    Manufacturer
    SUNRISE MEDICAL (US) LLC
    Product Code
    IOR
    PMA / PMN Number
    K072153
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IT APPEARS THAT THE WHEELCHAIR AND/OR PARTS INVOLVED IN THIS INCIDENT ARE NOT BEING RETURNED TO SUNRISE MEDICAL (US) LLC. WE WILL MAKE EVERY EFFORT TO COMPLETE AN INVESTIGATION THROUGH EITHER OBTAINING PICTURES OR VIDEO OF THE CHAIR INVOLVED, OR BY PERFORMING AN INVESTIGATION ON A CHAIR OF EQUIVALENT CONSTRUCTION. IF AND WHEN MORE INFORMATION CAN BE OBTAINED FROM THAT INVESTIGATION, A FOLLOW-UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    DEALER ALLEGES THAT THE CASTER HARDWARE FAILED CAUSING THE END USER TO FALL OUT OF THE CHAIR. DEALER REPORTED THAT THE END USER WENT TO THE HOSPITAL AND RECEIVED STITCHES. ADDITIONAL INFORMATION ON THIS INCIDENT CAN'T BE OBTAINED AT THIS TIME DUE TO LEGAL INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293208 QUICKIE 2 LITE WHEELCHAIR, MECHANICAL IOR SUNRISE MEDICAL (US) LLC EIQ2N

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R