BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICKIE Q7

    MDR report key: 2839304 · Received November 15, 2012

    Report

    Report Number
    2937137-2012-00019
    Event Type
    Injury
    Date Received
    November 15, 2012
    Date of Event
    June 17, 2011
    Report Date
    October 29, 2012
    Manufacturer
    SUNRISE MEDICAL (US) LLC
    Product Code
    IOR
    PMA / PMN Number
    K973673
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS CURRENTLY A LEGAL ISSUE THAT DOES NOT INCLUDE SUNRISE MEDICAL (US) LLC. HOWEVER, AS WE WERE MADE AWARE OF AN INCIDENT INVOLVING A SUNRISE MEDICAL (US) LLC WHEELCHAIR RESULTING IN AN INJURY, WE ARE FILING THIS MDR AS OUR DUE DILIGENCE. THE WHEELCHAIR INVOLVED IS NOT AVAILABLE FOR INVESTIGATION AND IS NOT BEING RETURNED. IF/WHEN MORE INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    THE END USER WAS BEING TRANSPORTED BY DOCTOR'S TRANSPORT SERVICE. THE DRIVER WAS LOADING HIM INTO THE VAN VIA THE RAMP WHEN HE LOST CONTROL OF THE WHEELCHAIR AND THE END USER AND HIS WHEELCHAIR FELL OVER BACKWARDS AND OFF THE SIDE OF THE RAMP. THE END USER SUFFERED A TORN ROTATOR CUFF, BROKEN RIBS, BROKEN WRIST, HEAD INJURY AND SEVERE NECK PAIN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention