BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICKIE 2

    MDR report key: 1935413 · Received November 11, 2010

    Report

    Report Number
    2937137-2010-00019
    Event Type
    Malfunction
    Date Received
    November 11, 2010
    Date of Event
    October 5, 2010
    Report Date
    October 14, 2010
    Manufacturer
    SUNRISE MEDICAL (US) LLC
    Product Code
    IOR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE END USER HAD THE ARMRESTS REMOVED BY THE DEALER. THE END USER STATED HE LOST HIS BALANCE AND FELL OUT OF HIS WHEELCHAIR. THE ARMRESTS WOULD PROVIDE SUPPORT AND STABILITY TO THE END USER. SINCE THE END USER REQUESTED TO HAVE THE ARMRESTS REMOVED THIS MAY HAVE CONTRIBUTED TO THE ALLEGED INCIDENT. THE WHEELCHAIR IS NOT BEING RETURNED AND WE WILL NOT HAVE AN OPPORTUNITY TO EVALUATE THE CHAIR. THE END USER HAS REQUESTED TO HAVE NEW ARMRESTS ADDED TO HIS CHAIR FOR MORE SUPPORT. WE HAVE CLOSED OUT OUR INVESTIGATION AS THE WHEELCHAIR WAS REC'D BY THE END USER WITHIN SPECIFICATION AND THEN ALTERED BY THE END USER'S REQUEST WHICH MAY HAVE CONTRIBUTED TO THE ALLEGED INCIDENT.

    Description of Event or Problem · 1

    END USER CALLED IN TO SUNRISE MEDICAL (US) LLC (B)(6) 2010 AND SPOKE TO A CUSTOMER SERVICE REP. END USER ALLEGES ON (B)(6) 2010 WHEN HE WAS OUTSIDE HIS HOME HE LOST HIS BALANCE AND FELL OUT OF HIS WHEELCHAIR. HE CLAIMS HE BROKE A FEW RIBS AND WAS TAKEN TO THE HOSPITAL. END USER DID NOT PROVIDE ANY MEDICAL INFORMATION IN REGARDS TO HIS ALLEGED INJURIES. END USER DID NOT PROVIDE ANY DATES OR DETAILS OF THE ALLEGED MEDICAL TREATMENT HE REC'D. END USER STATED THAT HE REQUESTED THE DEALER TO REMOVE HIS ARM RESTS LAST YEAR. END USER NOW IS REQUESTING HIS ARM RESTS PUT BACK ON HIS CHAIR FOR MORE SUPPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization