BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAWKINS II BREAST LOCALIZATION NEEDLE

    MDR report key: 35707 · Received June 27, 1996

    Report

    Report Number
    35707
    Event Type
    Malfunction
    Date Received
    June 27, 1996
    Date of Event
    March 20, 1996
    Report Date
    April 1, 1996
    Manufacturer
    MEDICAL DEVICE TECHNOLOGY, INC.
    Product Code
    MIJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    TWO BREAST LOCALIZATION NEEDLES INSERTED WITHOUT DIFFICULTY (MAMMOGRAPHICALLY GUIDED). SATISFACTORY POSITION CONFIRMED. SECURED IN PLACE AND PT SENT TO SURGERY. WHILE DISSECTING DOWN AND AROUND THE MORE ANTERIOR HOOK WIRE, SURGEON WAS SIMPLY HOLDING THE WIRE AND IT SNAPPED OFF. SURGEON DENIES CUTTING, BENDING OR APPLYING UNDUE TRACTION. ABLE TO DISSECT AROUND THE REMAINING FRAGMENT OF WIRE AND REMOVE IT. THE MORE POSTERIOR WIRE REMOVED WITHOUT DIFFICULTY. SMALL FRAGMENT RETAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HAWKINS II BREAST LOCALIZATION NEEDLE BREAST LOCALIZATION NEEDLE MIJ MEDICAL DEVICE TECHNOLOGY, INC. * 53042786

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other