BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TROPHIE RADIOLOGIE MODEL AD 332

    MDR report key: 1293887 · Received January 22, 2009

    Report

    Report Number
    MW5009652
    Event Type
    Injury
    Date Received
    January 22, 2009
    Date of Event
    March 5, 2007
    Report Date
    January 22, 2009
    Manufacturer
    TROPHIE RADIOLOGIE, SA
    Product Code
    EAP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    DENTAL TECHNICIAN WAS INJURED IN 2007, WHEN WALL-MOUNTED X-RAY MACHINE BROKE FROM ITS ARM AND FELL TOWARD SEATED DENTAL PATIENT. TECHNICIAN CAUGHT THE X-RAY MACHINE BEFORE IT HIT THE PATIENT; BUT IN DOING SO INJURED HER ARM, SHOULDERS, HANDS AND UPPER EXTREMITY. TECHNICIAN INSURED MEDICAL EXPENSES AND SUSTAINED A PERMANENT PARTIAL DISABILITY. PRODUCT WAS AN IRIX 70 SCISSOR ARM X-RAY MACHINE MANUFACTURED IN 1998 BY TROPHY RADIOLOGIES WHICH WAS PURCHASED IN 2003. FOLLOWING THE INCIDENT, SHOP SENT TECHNICIAN'S EMPLOYER A QUESTIONNAIRE WITH DIAGRAMS REQUESTING INFORMATION ABOUT THE LOCATION OF THE BREAK - INDICATING THIS IS NOT AN UNKNOWN PROBLEM FOR THEM AND THAT THESE MACHINES HAVE A HISTORY OF BREAKING BECAUSE OF INSUFFICIENT STRENGTH OF THE SCISSOR ARM. FURTHER RESEARCH INDICATES THAT ANOTHER COUNTRIES KNEW OF THE PROBLEM AND ISSUED WARNINGS TO DENTISTS IN 1995 AND 2001 RESPECTIVELY TO BEWARE AND CONTACT THE MANUFACTURER, ETC. NO FDA RECALL COULD BE PRESENTLY LOCATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TROPHIE RADIOLOGIE MODEL AD 332 WALL MOUNTED DENTAL X-RAY MACHINE EAP TROPHIE RADIOLOGIE, SA AD 332

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention