BEUDAMED
    FDA Adverse Event Other Summary report: N

    MICROTARGETING ELECTRODES

    MDR report key: 1884147 · Received October 13, 2010

    Report

    Report Number
    3005677147-2010-00008
    Event Type
    Other
    Date Received
    October 13, 2010
    Date of Event
    September 17, 2010
    Report Date
    September 17, 2010
    Manufacturer
    FHC, INC.
    Product Code
    GZL
    PMA / PMN Number
    K033173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS WAS A WRONG LABEL ON PRODUCT ERROR. THE PRODUCT WAS LABELED AS A SINGLE ELECTRODE WHEN IT WAS ACTUALLY AN ARRAY ELECTRODE. THERE WAS NOT PT OR SURGERY IMPACT AS THE PROBLEM WAS DISCOVERED PRIOR TO ANY SURGERY THE FACILITY PERFORMS BOTH ARRAY AND SINGLE ELECTRODE RECORDINGS.

    Description of Event or Problem · 1

    (B)(4) SALES PERSON, WHO WAS ATTENDING A CASE, REPORTED TO (B)(4) THAT THE FACILITY HAD RECENTLY PURCHASED STERILE MICROELECTRODES BUT THAT HE COULD NOT TELL THE SINGLE AND ARRAY MICROELECTRODE PACKAGES APART. THE FACILITY PERFORMS BOTH ARRAY AND SINGLE ELECTRODE RECORDINGS. BOTH PACKAGES WERE LABELED AS IF THEY WERE SINGLE MICROELECTRODES. THERE WAS NO SURGERY OR PATIENT IMPACT AS THIS WAS DISCOVERED PRIOR TO SURGERY AND THE CASE PROCEEDED AS SCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROTARGETING ELECTRODES ELECTRODES GZL FHC, INC. 557051

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other MICROTARGETING DRIVE SYSTEM