BEUDAMED
    FDA Adverse Event Other Summary report: N

    EXTENDED ACRYLIC WINGBOARD

    MDR report key: 974597 · Received January 4, 2008

    Report

    Report Number
    1932738-2007-00003
    Event Type
    Other
    Date Received
    January 4, 2008
    Date of Event
    December 5, 2007
    Report Date
    December 27, 2007
    Manufacturer
    CIVCO MEDICAL SOLUTIONS, MED-TEC INC.
    Product Code
    KXJ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE WINGBOARD HAS AN EXPECTED LIFE OF 12 MONTHS. THE UNIT INVOLVED IN THIS INCIDENT WAS 3 YEARS OLD (SHIPPED IN NOVEMBER 2004). THIS INCIDENT MAY HAVE BEEN EXACERBATED BY THE AGE OF THE DEVICE. MISUSE OF THE DEVICE MAY HAVE ALSO CONTRIBUTED TO THIS INCIDENT. THE INSTRUCTIONS FOR USE INCLUDE NOTES/WARNINGS FOR PATIENTS TO USE LIGHT FORCE ON THE HANDLES FOR SECURITY AND COMFORT. REPOSITIONING USING THE HANDLES PLACED EXCESSIVE FORCE ON THE DEVICE WHICH CONTRIBUTED TO THIS EVENT. THE PATIENT INJURY WAS MINOR AND LIMITED TO A BRUISE. PATIENT WAS DOING FINE THE DAY FOLLOWING THE INCIDENT.

    Description of Event or Problem · 1

    THE PATIENT WAS REPOSITIONING THEMSELVES BY BENDING OF THE KNEES AND HOLDING ONTO THE T-BAR WHICH IS ATTACHED TO THE WINGBOARD. THE WINGBOARD ROSE UP OFF OF THE TABLE AND BROKE IN HALF CAUSING THE TOP OF THE T-BAR TO HIT THE PATIENT'S HEAD. THE PATIENT WAS GIVEN ICE TO PLACE ON THE BRUISE AND ACETAMINOPHEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXTENDED ACRYLIC WINGBOARD EXTENDED ACRYLIC WINGBOARD KXJ CIVCO MEDICAL SOLUTIONS, MED-TEC INC. MT-WB06 9132/9666

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR