BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMV AMERICA PINHOLE COLLIMATER FOR FX 40 GAME CAMERA

    MDR report key: 35545 · Received July 1, 1996

    Report

    Report Number
    35545
    Event Type
    Malfunction
    Date Received
    July 1, 1996
    Date of Event
    May 23, 1996
    Report Date
    May 31, 1996
    Manufacturer
    SMV AMERICA
    Product Code
    IYX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ASSOCIATE WAS IN THE PROCESS OF LINING UP THE PINHOLE COLLIMATOR TO BE PLACED AND SECURED ON THE SURFACE OF THE DETECTOR HEAD WHEN PT FELL OFF OF ITS STAND AND ONTO THE FLOOR. WT OF COLLIMATOR 500 LBS. NO INJURY TO PTS OR ASSOCIATE. MFR NOTIFIED OF INCIDENT 5/23/96 AND EXAMINED EQUIPMENT ON-SITE. COLLIMATOR IN THE PROCESS OF BEING RETURNED TO THE MFR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMV AMERICA PINHOLE COLLIMATER FOR FX 40 GAME CAMERA PINHOLE COLLIMATER FOR FX 40 GAME CAMERA IYX SMV AMERICA UNK NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other