BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICKIE QXI

    MDR report key: 5066554 · Received September 9, 2015

    Report

    Report Number
    9616084-2015-00004
    Event Type
    Injury
    Date Received
    September 9, 2015
    Date of Event
    August 9, 2015
    Report Date
    August 31, 2015
    Manufacturer
    SUNRISE MEDICAL PRIVADA MISIONES
    Product Code
    IOR
    PMA / PMN Number
    K072153
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE END USER'S HUSBAND STATED THAT HE FELT THERE WERE AREAS ON THE WHEELCHAIR FRAME THAT WERE TOO SHARP FOR HIS WIFE'S SKIN DURING TRANSFERS IN AND OUT OF THE WHEELCHAIR. HE USED HIS OWN DREMMEL TOOL TO GRIND DOWN THE AREAS HE FELT WERE SHARP. HE FEELS THE CHAIR IS NOW SAFE TO USE FOR HIS WIFE AND WILL NOT BE RETURNING THE CHAIR FOR INVESTIGATION. THE ASSEMBLY TEAM HAS ADDED AN ITEM TO THEIR FINAL INSPECTION CHECKLIST TO CHECK EACH WHEELCHAIR OF THIS TYPE FOR ANY SHARP AREAS DURING FINAL INSPECTION OF THE WHEELCHAIR. ENGINEERING AND DESIGN WILL FOLLOW UP IF ISSUES ARE FOUND DURING FINAL INSPECTIONS MOVING FORWARD. SINCE THIS SPECIFIC CHAIR IS NOT BEING RETURNED FOR INVESTIGATION, THIS INVESTIGATION IS CONSIDERED CLOSED AND NO FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    SUNRISE MEDICAL RECEIVED A LETTER FROM THE HUSBAND OF AN END USER STATING THAT MULTIPLE AREAS ON THE WHEELCHAIR WERE SHARP AND HIS WIFE'S LEGS HAD RECEIVED CUTS AND SCRAPES AS A RESULT DURING TRANSFERRING. ONE INSTANCE RESULTED IN HIS WIFE REQUIRING 18 STITCHES FROM A LACERATION FROM THE FOOTREST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    597977 QUICKIE QXI WHEELCHAIR, MANUAL IOR SUNRISE MEDICAL PRIVADA MISIONES EIF6

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Female Required Intervention