BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMER MAMMOLOK

    MDR report key: 13277 · Received May 17, 1994

    Report

    Report Number
    MW1001999
    Event Type
    Injury
    Date Received
    May 17, 1994
    Date of Event
    October 12, 1992
    Report Date
    May 6, 1994
    Manufacturer
    NORTH AMERICAN INSTRUMENT CORP.
    Product Code
    MIJ
    Report Source
    Voluntary report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS CASE WAS A NEEDLE LOCALIZED BREAST BIOPSY. THE NEEDLE HAD A HARPOON TIP AND UPON EXTRACTION OF THE SPECIMEN, THE HOOK OF THE HARPOON BROKE OFF IN PT'S BREAST TISSUE. AT PT'S REQUEST, A SECOND PROCEDURE WAS DONE TO EXTRACT THE REMAINING PORTION OF WIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMER MAMMOLOK HARPOON NEEDLE LOCALIZING WIRE MIJ NORTH AMERICAN INSTRUMENT CORP. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention