BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENEVAC, MEGADYNE E-Z CLEAN

    MDR report key: 3062664 · Received April 3, 2013

    Report

    Report Number
    3062664
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    March 18, 2013
    Report Date
    April 3, 2013
    Manufacturer
    I.C. MEDICAL
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US

    Narratives

    Description of Event or Problem · 1

    THE PLASTIC WHITE CASING THAT SURGEON HOLDS IN HIS HAND, BROKE OFF DURING USAGE. ALL PIECES WERE RETRIEVED.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?BILATERAL SKIN SPARING MASTECTOMY.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135414 PENEVAC, MEGADYNE E-Z CLEAN BLADE ELECTROSURGICAL PENEVAC WITH TUBE GEI I.C. MEDICAL * 4937

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR