BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICKIE LXI/LX

    MDR report key: 1884939 · Received October 21, 2010

    Report

    Report Number
    2937137-2010-00018
    Event Type
    Injury
    Date Received
    October 21, 2010
    Date of Event
    July 16, 2010
    Report Date
    October 1, 2010
    Manufacturer
    SUNRISE MEDICAL (US) LLC
    Product Code
    IOR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A SUNRISE MEDICAL (US) LLC QUALITY ENGINEER AND I REVIEWED THE PHOTOGRAPHS OF THE ALLEGED INCIDENT AND EVALUATED A SIMILAR CHAIR. WE DETERMINED THAT WHAT THE INDIVIDUAL IS DESCRIBING AS A "NAIL" IS ACTUALLY A LATCH STUD THAT IS CONNECTED TO THE LATCH BLOCK. IT HAS A FLAT ROUND HEAD SIMILAR TO A BOLT AND IS NOT SHARP LIKE A NAIL. OUR CONCLUSION IS THAT THE LATCH STUD WOULD ONLY BE EXPOSED IF THE HANGERS THAT HOLD THE FOOTRESTS WERE REMOVED FROM THE FRAME. THE PHOTOGRAPHS CLEARLY INDICATE THAT THE HANGERS WERE REMOVED. THE CHAIR WAS SENT WITH HANGERS AS SPECIFIED IN THE ORIGINAL ORDER TO A DEALER AS REQUESTED BY THE END USER. THE END USER OF THE WHEELCHAIR EITHER REMOVED THE HANGERS OR ASKED THE DEALER TO REMOVE THEM WHICH EXPOSED THE LATCH STUD. THE WHEELCHAIR WAS SENT TO THE DEALER (B)(6) WITHIN PROPER SPECIFICATION AND PASSED OUR QUALITY CONTROL FINAL INSPECTION PROCESS. THE END USER OR DEALER ALTERED THE WHEELCHAIR AND DID NOT MAINTAIN THE WHEELCHAIR PROPERLY BECAUSE, THE HANGERS WERE REMOVED EXPOSING THE LATCH STUD. PHOTOGRAPHS ARE AVAILABLE UPON REQUEST. THE CHAIR IS NOT BEING RETURNED FOR EVAL AND WE HAVE COMPLETED OUR INTERNAL INVESTIGATION.

    Description of Event or Problem · 1

    SUNRISE MEDICAL (US) LLC RECEIVED A COMPLAINT VIA EMAIL THROUGH OUR WEBMASTER COMPLAINT NOTIFICATION SYSTEM ON 10/1/2010. THE INDIVIDUAL ALLEGES THAT IN (B)(6) OF 2010, HER DAUGHTER AND SHE, WERE AT HER AUNT'S HOUSE VISITING. THE AUNT IS DISABLED AND IN A WHEELCHAIR. SHE ALLEGES THAT HER DAUGHTER WHO WAS APPROXIMATELY (B)(6) AT THE TIME FELL AND HIT HER EYE ON A WHAT SHE CLAIMS AND DESCRIBED AS A "NAIL" THAT WAS STICKING OUT. SHE CLAIMS, THE NAIL WAS VERY SHARP AND CAUSED A LACERATION ABOVE THE CHILD'S RIGHT EYE. THE CHILD WAS TAKEN TO THE EMERGENCY ROOM AND RECEIVED MEDICAL ATTENTION FOR THE LACERATION. WE DETERMINED THAT THIS ALLEGED INCIDENT OCCURRED ON (B)(6) 2010 FROM THE MEDICAL BILL WE RECEIVED FROM THE COMPLAINT ON 10/1/2010.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 16 MO Hospitalization