BEUDAMED
    FDA Adverse Event Summary report: N

    IRIX 70

    MDR report key: 1193545 · Received October 8, 2008

    Report

    Report Number
    8020825-2008-00003
    Date Received
    October 8, 2008
    Date of Event
    July 23, 2008
    Report Date
    August 10, 2008
    Manufacturer
    TROPHY RADIOLOGIE
    Product Code
    EAP
    Removal / Correction Number
    Z-1099/1101-5
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED CONDITION IS ATTRIBUTED TO A FAILURE OF THE SUPPORT ARM. THIS CONDITION WAS IDENTIFIED BY THE MFR IN 1995 AND CORRECTIVE ACTIONS WERE INSTITUTED. THE DEVICE CITED IN THIS REPORT IS INVOLVED IN RECALL Z-1099/1101-5.

    Description of Event or Problem · 1

    IRIX SCISSOR ARM BROKE AT KNUCKLE. ARM FELL AND STRUCK PT ON OR ABOUT HEAD. MEDICAL ATTENTION WAS OBTAINED. PT NAME NOT DISCLOSED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1