BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAMMOVISION CAMERA

    MDR report key: 167716 · Received May 14, 1998

    Report

    Report Number
    1418957-1998-00003
    Event Type
    Injury
    Date Received
    May 14, 1998
    Date of Event
    April 17, 1998
    Report Date
    May 14, 1998
    Manufacturer
    FISCHER IMAGING CORP.
    Product Code
    IZH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    A VOLUNTARY MEDWATCH FORM (ACCESS # 1013950) HAS BEEN SUMITTED RELATED TO THIS MDR. AT THIS TIME, CO WOULD LIKE TO UPDATE ANY RECORDS TO SHOW THAT AN MDR WAS FILED IN THE PROPER MANNER & WITHIN THE TIMEFRAMES SPECIFIED FOR REPORTING DEATHS, SERIOUS INJURIES, & MALFUNCTIONS. IF FURTHER INFO IS REQUIRED ON CO'S BEHALF, PLEASE NOTIFY CO IMMEDIATELY.

    Description of Event or Problem · 1

    CAMERA OVERHEATED & PT SUSTAINED FULL-THICKNESS BURN IN AREA IN CONTACT WITH CAMERA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAMMOVISION CAMERA CCD IMAGE RECEPTOR IZH FISCHER IMAGING CORP. 77225G-2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention