BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASAP

    MDR report key: 85639 · Received January 4, 1995

    Report

    Report Number
    85639
    Event Type
    Malfunction
    Date Received
    January 4, 1995
    Date of Event
    November 16, 1994
    Report Date
    November 28, 1994
    Manufacturer
    MEDI-TECH, INC
    Product Code
    KNW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    CORE GUN TESTED BEFORE ACTUAL BIOPSY. ONE SAMPLE OBTAINED WITH NO DIFFICULTY. ON SECOND ATTEMPT GUN WOULD SET BUT NOT RELEASE. A NEW GUN USED TO OBTAIN BIOPSY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASAP AUTOMATIC 15 GAUGE CORE BIOPSY SYSTEM KNW MEDI-TECH, INC * H43588

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other