BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDRAD MARK V PLUS

    MDR report key: 238406 · Received August 16, 1999

    Report

    Report Number
    1217116-1999-00015
    Event Type
    Injury
    Date Received
    August 16, 1999
    Date of Event
    June 18, 1999
    Report Date
    July 21, 1999
    Manufacturer
    MEDRAD, INC.
    Product Code
    DXT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    A CATH LAB IN THIS USER FACILITY HAS A HANEL/MAVIG TRIPLE ARM CEILING MOUNTED SUSPENSION WITH RADIATION SHIELD, SURGICAL LAMP AND INJECTOR HEAD ATTACHED. REPORTEDLY, AS THE RADIOLOGY TECH WAS MOVING THE INJECTOR HEAD SUSPENSION ARM TOWARDS THE CEILING, THE ELBOW OF THE ARM HIT THE CEILING AND THE INJECTOR HEAD DETACHED FROM THE SUSPENSION ARM AND FELL STRIKING A RADIOLOGY TECH IN THE SHOULDER AND THEN HER SIDE. THE INJECTOR HEAD THEN DANGLED FROM ITS CABLE. REPORTEDLY, THE RADIOLOGY TECH WAS IN A LOT OF PAIN AND SHE WAS TAKEN TO THE HOSPITAL'S EMERGENCY ROOM FOR MEDICAL TREATMENT. THE EXTENT OF INJURY IS UNKNOWN AT THIS TIME. PRELIMINARY FINDINGS AS TO THE CAUSE OF THIS EVENT INDICATED THAT THE SET SCREW THAT HOLDS THE INJECTOR HEAD TO THE SUSPENSION ARM HAD LOOSENED. THE INJECTOR HEAD AND THE SUSPENSION ARM FOR THE INJECTOR HEAD IS SUPPLIED BY MEDRAD, INC..

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDRAD MARK V PLUS INJECTOR DXT MEDRAD, INC. MARK V PLUS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention