BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROTARGETING ELECTRODE

    MDR report key: 1218525 · Received October 29, 2008

    Report

    Report Number
    3005677147-2008-00010
    Event Type
    Malfunction
    Date Received
    October 29, 2008
    Date of Event
    October 1, 2008
    Report Date
    October 1, 2008
    Manufacturer
    FHC, INC.
    Product Code
    GZL
    PMA / PMN Number
    K991522
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DISTRIBUTOR REPRESENTATIVE ATTENDED THE CASE DESCRIBED ABOVE. THE REPRESENTATIVE NOTED THE BEND IN THE ELECTRODE AS WELL AS THE COMPROMISE TO THE PACKAGE STERILITY. THE ELECTRODE AND PACKAGING HAVE NOT BEEN RETURNED TO FHC FOR EVALUATION. DISTRIBUTOR REPRESENTATIVE STATED THAT MISHANDLING OF THE PRODUCT AT THE USER FACILITY CANNOT BE RULED OUT AND THAT THE STERILE PACKAGING WAS COMPLETELY OPEN. REVIEW OF PACKAGING PROCESS FOR THIS PRODUCT AT MANUFACTURER HAS SHOWN THAT THIS TYPE OF PRODUCT PROBLEM IS UNLIKELY. PRODUCT HAS BEEN REQUESTED FOR EVALUATION. IF PRODUCT IS RETURNED, A FOLLOW-UP REPORT WILL BE FILED DOCUMENTING THE EVALUATION. THIS REPORT IS BEING SUBMITTED BECAUSE IN THE EVENT OF USE OF A NON-STERILE DEVICE, THERE IS A POTENTIAL FOR HARM TO THE PATIENT.

    Description of Event or Problem · 1

    DISTRIBUTOR SALES REPRESENTATIVE REPORTED AN INCIDENT WHERE AN ELECTRODE WAS BENT AT THE DISTAL END AND THE STERILE PACKAGING WAS COMPROMISED. PRODUCT WAS NOT USED WITH THE PATIENT, AND THERE WERE NO ADVERSE AFFECTS OF THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROTARGETING ELECTRODE GZL FHC, INC. 34680 6349610

    Patients

    Seq Age Sex Outcome Treatment
    1 Other