BEUDAMED
    FDA Adverse Event Other Summary report: N

    MAMMO-DIAGNOSIS V-M

    MDR report key: 66218 · Received January 7, 1997

    Report

    Report Number
    66218
    Event Type
    Other
    Date Received
    January 7, 1997
    Date of Event
    October 1, 1996
    Report Date
    October 3, 1996
    Manufacturer
    PHILLIPS, CUSTOMERS SUPPORT
    Product Code
    IZH
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PT WAS POSITIONED AND THEN AN EXPOSURE WAS TAKEN. DURING THE EXPOSURE, THE PT FELT A SHOCK BELOW HER LEFT BREAST AND ON THE RIGHT SIDE OF HER FACE. SHE ALSO SAW FLASH OF WHITE LIGHT WHICH SHE BELIEVES TO HAVE BEEN AN ARC OF ELECTRICITY. THE PT SUFFERED A HEADACHE AND A 4-5 INCH X 1/8 INCH BURN BELOW HER LEFT BREAST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAMMO-DIAGNOSIS V-M MAMMOGRAM IZH PHILLIPS, CUSTOMERS SUPPORT 4512-290-27531 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 5 MO Other 9100267.| 24 X 30 BUCKY GRID, MOD #: 9804-051-10009, SN #: