BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEREOGUIDE PRONE BREAST BIOPSY SYS W/DIGITAL SPOT MAMMOMGRA

    MDR report key: 19201 · Received January 27, 1995

    Report

    Report Number
    MW1004897
    Event Type
    Malfunction
    Date Received
    January 27, 1995
    Date of Event
    December 19, 1994
    Report Date
    January 13, 1995
    Manufacturer
    LORA MEDICAL SYSTEMS, INC.
    Product Code
    IZH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT IN PRONE POSITION FOR STEROTACTIC BREAST BIOPSY. FOUR BIOPSY SPECIMEN HAD BEEN TAKEN WHEN MACHINE BROKE DOWN. TROUBLE-SHOOTING WAS DONE BUT EQUIPMENT COULD NOT BE BROUGHT ON LINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STEREOGUIDE PRONE BREAST BIOPSY SYS W/DIGITAL SPOT MAMMOMGRA BREAST BIOPSY UNIT IZH LORA MEDICAL SYSTEMS, INC. 3000-A 0935 TABLE 8-004-0004

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR