BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMER MAMMALOK GOLD ANGIOTECH

    MDR report key: 1034013 · Received April 24, 2008

    Report

    Report Number
    MW5006407
    Event Type
    Injury
    Date Received
    April 24, 2008
    Date of Event
    April 23, 2008
    Report Date
    April 24, 2008
    Manufacturer
    MEDICAL DEVICE TECHNOLOGIES
    Product Code
    MIJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT UNDERWENT NEEDLE LOCALIZATION OF THE RIGHT BREAST. NEEDLE FOUND ON PATIENT'S ABDOMEN; UNCLEAR HOW THE NEEDLE BECAME MISPLACED. CASE NEEDED TO BE RESCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMER MAMMALOK GOLD ANGIOTECH BREAST LOCALIZATION NEEDLE MIJ MEDICAL DEVICE TECHNOLOGIES 231050G - 20G X 5CM- 73231 KOZ

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other