BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZERO GRAVITY RADIATION PROTECTION SYSTEM

    MDR report key: 6275611 · Received January 25, 2017

    Report

    Report Number
    6275611
    Event Type
    Malfunction
    Date Received
    January 25, 2017
    Date of Event
    December 6, 2016
    Report Date
    January 17, 2017
    Manufacturer
    CONTOUR FABRICATORS, INC.
    Product Code
    IWO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING REPOSITIONING OF THE ZERO GRAVITY RADIATION PROTECTION SYSTEM , THE LEAD APRON RETENTION ARM SLID OUT FROM THE RETAINING SLEEVE CAUSING THE SYSTEM TO FREE FALL TO THE GROUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    60046 ZERO GRAVITY RADIATION PROTECTION SYSTEM APRON, LEADED IWO CONTOUR FABRICATORS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1