BEUDAMED
    FDA Adverse Event Other Summary report: N

    MICROTARGETING ELECTRODE

    MDR report key: 1914440 · Received November 23, 2010

    Report

    Report Number
    3005677147-2010-00011
    Event Type
    Other
    Date Received
    November 23, 2010
    Date of Event
    November 10, 2010
    Report Date
    November 10, 2010
    Manufacturer
    FHC, INC.
    Product Code
    GZL
    PMA / PMN Number
    K033173
    Removal / Correction Number
    3005677147-11/23/10-003C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L LOT #: 553781. THE PRODUCT LABELING WAS RETURNED FOR EVAL. THE LONGER ELECTRODE WAS AN INCORRECT ELECTRODE TYPE AND WAS 52MM LONGER THAN THE CORRECT ELECTRODE. THIS ERROR SHOULD HAVE BEEN NOTED DURING FINAL PRODUCT INSPECTION AND PACKAGING. DUE TO THE POTENTIAL FOR PT INJURY FROM THIS ERROR, THE PRODUCT LOTS HAVE BEEN RECALLED AND WERE INSPECTED BY FHC SALES PERSONNEL AT THE DISTRIBUTED LOCATIONS TO ENSURE THE ELECTRODES IN THE PACKAGES WERE THE CORRECT LENGTH. NO ADD'L ABNORMALITIES WERE FOUND. FHC CONSIDERS THIS AN ISOLATED INCIDENT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO FHC/(B)(4) PROCEDURAL SUPPORT SPECIALIST, AN INCIDENT WHERE TWO ELECTRODES FROM THE SAME STERILE PACKAGE WERE OF DIFFERENT LENGTH WHEN THEY SHOULD HAVE BEEN THE SAME. A MEMBER OF THE OPERATING ROOM STAFF NOTICED WHEN SHE OPENED THE PRODUCT THAT THE ELECTRODES WERE DIFFERENT LENGTHS; ONE WAS ABOUT 50MM LONGER WITH A DIAMETER ABOUT 1/10TH LARGER THAN THE LABEL INDICATED. ELECTRODES WERE PUT ASIDE AND ANOTHER PACKAGE WAS USED. THERE WAS NO PT IMPACT AS A RESULT OF THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROTARGETING ELECTRODE ELECTRODE GZL FHC, INC. 550311

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other MICROTARGETING DRIVE SYSTEM