BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROTARGETING ELECTRODE

    MDR report key: 1218527 · Received October 29, 2008

    Report

    Report Number
    3005677147-2008-00011
    Event Type
    Malfunction
    Date Received
    October 29, 2008
    Date of Event
    October 2, 2008
    Report Date
    October 2, 2008
    Manufacturer
    FHC, INC.
    Product Code
    GZL
    PMA / PMN Number
    K991522
    Removal / Correction Number
    3005677147-10/23/08-002-
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED TO FHC FOR EVALUATION. THE LONGER ELECTRODE WAS AN INCORRECT ELECTRODE TYPE AND WAS 27MM LONGER THAN THE CORRECT ELECTRODE. THIS ERROR SHOULD HAVE BEEN NOTED DURING FINAL PRODUCT INSPECTION AND PACKAGING. DUE TO THE POTENTIAL FOR PATIENT INJURY FROM THIS ERROR, THE PRODUCT LOT HAS BEEN RECALLED, AND WILL BE INSPECTED TO ENSURE IT IS THE CORRECT LENGTH.

    Description of Event or Problem · 1

    DISTRIBUTOR SALES REPRESENTATIVE REPORTED AN INCIDENT WHERE TWO ELECTRODES FROM THE SAME STERILE PACKAGE WERE OF DIFFERENT LENGTH WHEN THEY SHOULD HAVE BEEN THE SAME. THE SCRUB NURSE NOTICED WHEN SHE OPENED THE KIT THAT THE ELECTRODES WERE DIFFERENT LENGTHS; ONE WAS 245MM AND THE OTHER WAS 272MM. ELECTRODES WERE PUT ASIDE AND ANOTHER PACKAGE WAS USED. THERE WAS NO PATIENT IMPACT AS A RESULT OF THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROTARGETING ELECTRODE GZL FHC, INC. FC4000SP

    Patients

    Seq Age Sex Outcome Treatment
    1 Other