BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICKIE 2 LITE

    MDR report key: 2023360 · Received March 16, 2011

    Report

    Report Number
    2937137-2011-00005
    Event Type
    Injury
    Date Received
    March 16, 2011
    Date of Event
    February 19, 2011
    Report Date
    February 23, 2011
    Manufacturer
    SUNRISE MEDICAL (US) LLC
    Product Code
    IOR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE WHEELCHAIR HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION AND IT IS UNKNOWN IF OR WHEN THE MANUFACTURER MAY HAVE AN OPPORTUNITY TO EVALUATE THE DEVICE. MANUFACTURER DOES NOT HAVE ALL OF THE DETAILS OF THE REPORTABLE EVENT AT THIS TIME TO COMPLETE OUR INVESTIGATION.

    Description of Event or Problem · 1

    END USER CONTACTED DEALER ON (B)(6) 2011 TO REPORT THAT ALLEGEDLY ON (B)(6) 2011, AN ADVERSE EVENT OCCURRED WHILE IN HIS WHEELCHAIR. HE CLAIMS THE BOLTS CAME LOOSE RESULTING IN A FALL AND SUBSEQUENT INJURY. DEALER CLAIMS THE END USER CALLED HIM ON (B)(6) 2011 STATING THE RIGHT CASTER PLATE BOLTS HAD LOOSENED. THE END USER CLAIMS WHILE HE WAS NAVIGATING A TURN IN THE LIVING ROOM, THE CASTER HOUSING SEPARATED FROM THE WHEELCHAIR AND THE WHEELCHAIR TIPPED OVER RESULTING IN THE END USER FALLING. THE FALL ALLEGEDLY CAUSED THE END USER TO HIT HIS HEAD ON THE WOODEN ARM OF THE COUCH. ON (B)(6) 2011 THE DEALER NOTIFIED SUNRISE MEDICAL ((B)(4)) THE DEALER SAID THAT AS FAR AS HE KNEW THE END USER DID NOT SEEK MEDICAL ATTENTION AT THE TIME OF THE ALLEGED EVENT BUT THE DEALER DID SAY THE END USER ATTEMPTED TO OR WAS GOING TO CONTACT A NEUROLOGIST. DEALER UNABLE TO CONTACT OR OBTAIN ANY ADDITIONAL INFORMATION FROM THE END USER REGARDING THE ALLEGED INJURIES SUSTAINED. COMPLAINT WAS REVIEWED BY THE REGULATORY AFFAIRS/QUALITY ASSURANCE SPECIALIST ON (B)(6) 2011. END USER CLAIMS TO HAVE HAD TWO PRIOR HEAD INJURIES IN THE LAST TWO YEARS AND IS NOW VERY RELUCTANT TO GET BACK IN THE WHEELCHAIR.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other