BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICKIE Q7

    MDR report key: 3240273 · Received July 18, 2013

    Report

    Report Number
    2937137-2013-00021
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    June 19, 2013
    Report Date
    June 19, 2013
    Manufacturer
    SUNRISE MEDICAL (US) LLC.
    Product Code
    IOR
    PMA / PMN Number
    K973673
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IT APPEARS THAT THE WHEELCHAIR AND/OR PARTS INVOLVED IN THIS INCIDENT ARE BEING RETURNED TO SUNRISE MEDICAL (US) LLC. IF AND WHEN THE CHAIR/PARTS ARE RECEIVED, OUR INTERNAL FAILURE INVESTIGATOR WILL COMPLETE THE INVESTIGATION AND A FOLLOW-UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    DEALER REPORTED THAT ON (B)(6) 2013, THE END USER SUFFERED INJURIES IN THEIR QUICKIE Q7 WHEELCHAIR. THE EXTENT OF THE ALLEGED INJURIES ARE UNKNOWN AT THIS TIME. DEALER ALLEGED THAT THE CASTER SPLINE SHIFTED CAUSING THE CASTER TO BEND BACK AND THEN FLIP FORWARD. DEALER STATED THAT THIS CAUSED THE END USER TO FALL FORWARD OUT OF THE WHEELCHAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333299 QUICKIE Q7 WHEELCHAIR, MECHANICAL IOR SUNRISE MEDICAL (US) LLC. EIR4

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention