BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIPPIE GS

    MDR report key: 3144609 · Received May 30, 2013

    Report

    Report Number
    2937137-2013-00011
    Event Type
    Injury
    Date Received
    May 30, 2013
    Date of Event
    April 30, 2013
    Report Date
    May 1, 2013
    Manufacturer
    SUNRISE MEDICAL (US) LLC
    Product Code
    IOR
    PMA / PMN Number
    K983639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6) REPORTED THAT REPAIRS HAVE BEEN MADE TO THE END USER'S WHEELCHAIR. IT APPEARS THAT THE WHEELCHAIR AND/OR PARTS INVOLVED IN THIS INCIDENT ARE NOT BEING RETURNED TO SUNRISE MEDICAL (US) LLC. WE WILL MAKE EVERY EFFORT TO COMPLETE AN INVESTIGATION THROUGH EITHER OBTAINING PICTURES OR VIDEO OF THE CHAIR INVOLVED, OR BY PERFORMING AN INVESTIGATION ON A CHAIR OF EQUIVALENT CONSTRUCTION. IF AND WHEN MORE INFO CAN BE OBTAINED FROM THAT INVESTIGATION, A F/U REPORT WILL BE FILED.

    Description of Event or Problem · 1

    PER (B)(6), THE BOLT THAT HOLDS THE RIGHT SIDE CASTER HOUSING TO THE FRAME SHEARED WHILE BRINGING THE CHAIR DOWN A RAMP. COOKIE REPORTED THAT THE CHAIR THEN TIPPED FORWARD WHILE THE CHAIR WAS ALREADY OFF THE RAMP AND BEING INSPECTED BY THE END USER'S MOTHER. THE END USER HIT HER HEAD ON THE CEMENT WHICH CAUSED A CUT RESULTING IN THE NEED OF MEDICAL GLUE TO SHUT THE WOUND CLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237854 ZIPPIE GS WHEELCHAIR, MECHANICAL IOR SUNRISE MEDICAL (US) LLC EIZGS

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Required Intervention