BEUDAMED
    FDA Adverse Event Other Summary report: N

    E-Z CLEAN ELECTRODE, BLADE, MODIFIED, BAYONET

    MDR report key: 1523140 · Received November 5, 2009

    Report

    Report Number
    1721194-2009-00004
    Event Type
    Other
    Date Received
    November 5, 2009
    Date of Event
    October 7, 2009
    Report Date
    November 5, 2009
    Manufacturer
    MEGADYNE MEDICAL PRODUCTS
    Product Code
    GEI
    PMA / PMN Number
    K081791
    Removal / Correction Number
    1721194-10/12/2009-001-R
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE FAILURE WAS IDENTIFIED ON THE BOX LABEL AND SEVERAL POUCH LABELS WITHIN THE LOT. THE CAUSE OF THE FAILURE IS DETERMINED TO BE HUMAN ERROR IN ENTERING AN INCORRECT EXPIRATION DATE AND FAILURE TO PERFORM THE REQUIRED LABEL RECONCILIATION FOR A SECOND RUN OF LABELS. CORRECTIVE ACTIONS INCLUDE: IMPROVEMENTS IN THE DATA ENTRY PROCESS AND DISCIPLINARY ACTION RELATED TO THE OPERATOR'S FAILURE TO FOLLOW PROCEDURE.

    Description of Event or Problem · 1

    AS REPORTED BY THE DISTRIBUTOR - THREE (3) BOXES HAD AN EXPIRATION DATE OF 07/2104. IT IS BELIEVED THIS WAS A TYPO FROM LABELING AND SHOULD BE 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 E-Z CLEAN ELECTRODE, BLADE, MODIFIED, BAYONET E-Z CLEAN ELECTROSURGICAL ELECTRODES GEI MEGADYNE MEDICAL PRODUCTS 0029M 91469

    Patients

    Seq Age Sex Outcome Treatment
    1