BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICKIE LXI/LX WHEELCHAIR

    MDR report key: 2111234 · Received May 10, 2011

    Report

    Report Number
    2937137-2011-00008
    Event Type
    Injury
    Date Received
    May 10, 2011
    Date of Event
    January 27, 2009
    Report Date
    April 26, 2011
    Manufacturer
    SUNRISE MEDICAL (US) LLC
    Product Code
    IOR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A SUNRISE MEDICAL (US) LLC ACCOUNT MANAGER DID COMPLETE A VISUAL EXAMINATION OF THE WHEELCHAIR AT THE PLAINTIFF'S COUNSEL'S OFFICE. THE ACCOUNT MANAGER HAD SOME SUGGESTIONS AS TO A POTENTIAL ROOT CAUSE BUT THE INFORMATION CANNOT BE CONFIRMED UNLESS THE WHEELCHAIR IS EVALUATED BY OUR INTERNAL FAILURE INVESTIGATOR AND QUALITY ENGINEERS. THE WHEELCHAIR HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION AND WE DO NOT ANTICIPATE IT'S RETURN DUE TO THE ONGOING LITIGATION. MANUFACTURER DOES NOT HAVE ALL OF THE DETAILS OF THE REPORTABLE EVENT AT THIS TIME TO COMPLETE OUR INVESTIGATION. WE WILL CONTINUE TO INVESTIGATE THIS COMPLAINT AND SUBMIT A FOLLOW UP REPORT WHEN THE INVESTIGATION IS FINALIZED.

    Description of Event or Problem · 1

    SUNRISE MEDICAL (US) LLC WAS SERVED WITH A SUMMONS FOR A CIVIL COMPLAINT REGARDING AN ALLEGED EVENT THAT OCCURRED ON (B)(6) 2009. THE COMPLAINT ALLEGES THAT ON (B)(6) 2009 AN END USER WAS INJURED WHEN HE ALLEGEDLY FELL DOWN THROUGH THE WHEELCHAIR FRAME WHEN THE SCREWS HOLDING ONE SIDE OF THE WHEELCHAIR SEAT SLING TO THE FRAME ALLEGEDLY FAILED. THE SUMMONS DID NOT INDICATE A SERIOUS INJURY AND ONLY GAVE US THE MODEL LX/LXI AND SERIAL NUMBER (B)(4) OF THE WHEELCHAIR INVOLVED IN THE ALLEGED INCIDENT. THERE WAS NO INITIAL INFORMATION IN THE ORIGINAL SUMMONS REGARDING THE INJURIES SUSTAINED. WE SEARCHED OUR DATABASE FROM (B)(6) 2009 UNTIL (B)(6) 2011 TO SEE IF ANY COMPLAINTS WERE ENTERED IN RELATION TO THAT SERIAL NUMBER AND NO COMPLAINTS WERE RECEIVED OR ENTERED. I RECEIVED THE INJURY INFORMATION FROM OUR ATTORNEYS ONLY AFTER THEY REQUESTED A RESPONSE FROM THE PLAINTIFF. THE COMPLAINT WAS ENTERED ON (B)(6) 2011. THE END USER IS CLAIMING TO HAVE A CERVICAL, THORACIC, AND LUMBAR SPRAIN/STRAIN RESULTING IN INJURIES AND PAIN TO PLAINTIFF'S HEAD, THE BACK OF HIS HEAD, NECK, ARMS, BOTH HANDS, MIDDLE BACK, LOWER BACK, AND PAIN FLOWING ALL THE WAY DOWN TO THE BUTTOCK IN HIS RIGHT LEG.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization