BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UT69 TABLE MOUNTED RADIATION SHIELDS

    MDR report key: 1833208 · Received September 9, 2010

    Report

    Report Number
    MW5017368
    Event Type
    Malfunction
    Date Received
    September 9, 2010
    Date of Event
    July 14, 2010
    Report Date
    September 9, 2010
    Manufacturer
    MAVIG GMBH
    Product Code
    KPY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE UT69TABLE SHIELD HAS A U PROFILE THAT COVERS THE SHIELDS SUPPORT BAR AND THE PROFILE EDGES WERE SHARP CAUSING PAPER CUT TYPE INJURIES ON THE INSTALLER. (B)(6) DID A QUALITY CHECK AND FOUND OUT THAT THE MANUFACTURE DID NOT BURR (SAND AND POLISH) THE EDGES WHICH CAUSED THIS ISSUE. (B)(6) HAD THE MANUFACTURE FIX THE ISSUE AND WE WENT THROUGH AND REPLACED ALL THE DEFECTIVE PROFILES WITH ONES THAT WERE BURRED AND SANDED SO THEY HAD A SMOOTH EDGE AND DID NOT CAUSE ANY MORE CUTS. THE MANUFACTURER OF THE U PROFILES DETECTED THAT THE PROBLEM CAME FROM A NON SUFFICIENTLY TRAINED EMPLOYEE, HAS SINCE INCREASED HIS QUALITY AND TRAINING PROCESS AND ADAPTED A LASER PROCESSED PRODUCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UT69 TABLE MOUNTED RADIATION SHIELDS UT69 KPY MAVIG GMBH UT6902-US

    Patients

    Seq Age Sex Outcome Treatment
    1 Other