BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCALIZING NEEDLE

    MDR report key: 32997 · Received May 14, 1996

    Report

    Report Number
    MW1009095
    Event Type
    Malfunction
    Date Received
    May 14, 1996
    Date of Event
    April 24, 1996
    Report Date
    April 30, 1996
    Manufacturer
    MANAN MEDICAL PRODUCTS, INC.
    Product Code
    MIJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING A PROCEDURE THE WIRE WAS INSERTED INTO A LUMP IN THE PT'S BREAST AND THE NEEDLE BROKE DURING THE MANIPULATION OF THE BREAST DURING SURGERY. THE HOOP ON THE END OF THE WIRE SEPARATED FROM THE ORIGINAL PIECE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOCALIZING NEEDLE LOCALIZING NEEDLE MIJ MANAN MEDICAL PRODUCTS, INC. M010896-1

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR