BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1 RIX-70

    MDR report key: 372769 · Received January 18, 2002

    Report

    Report Number
    8020825-2001-00007
    Event Type
    Malfunction
    Date Received
    January 18, 2002
    Date of Event
    December 14, 2001
    Report Date
    December 17, 2001
    Manufacturer
    TROPHY RADIOLOGIE
    Product Code
    EAP
    Removal / Correction Number
    Z-1099/1101/5
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SUPPORT ARM OF X-RAY BROKE. CAUSING UNIT TO FALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1 RIX-70 DENTAL X-RAY SYSTEM EAP TROPHY RADIOLOGIE NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA