BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEVICOR MEDICAL PRODUCTS, INC.

    MDR report key: 3074609 · Received April 18, 2013

    Report

    Report Number
    MW5029869
    Event Type
    Malfunction
    Date Received
    April 18, 2013
    Date of Event
    April 15, 2013
    Report Date
    April 18, 2013
    Manufacturer
    DEVICOR MEDICAL PRODUCTS, INC.
    Product Code
    KNW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DISTAL TIP OF MAMMO MARK APPLICATOR RETAINED DURING STEREOTACTIC BIOPSY PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    168258 DEVICOR MEDICAL PRODUCTS, INC. MAMMO MARK 2 KNW DEVICOR MEDICAL PRODUCTS, INC. D000MAM30081Y F11305206D1

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other