BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RANFAC BREAST MARKING/BRACKENING

    MDR report key: 2081800 · Received May 3, 2011

    Report

    Report Number
    MW5020496
    Event Type
    Malfunction
    Date Received
    May 3, 2011
    Date of Event
    April 29, 2011
    Report Date
    May 4, 2011
    Manufacturer
    RANFAC. CORP
    Product Code
    MIJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WIRE FRAGMENT BROKE OFF DURING PROCEDURE. SURGEON FOUND FRAGMENT AND USED A SECOND UNIT TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RANFAC BREAST MARKING/BRACKENING NONE MIJ RANFAC. CORP 21032615

    Patients

    Seq Age Sex Outcome Treatment
    1