BEUDAMED
    FDA Adverse Event Other Summary report: N

    MICROTARGETING ELECTRODE

    MDR report key: 2195260 · Received July 8, 2011

    Report

    Report Number
    3005677147-2011-00002
    Event Type
    Other
    Date Received
    July 8, 2011
    Date of Event
    June 8, 2011
    Report Date
    June 8, 2011
    Manufacturer
    FHC, INC.
    Product Code
    GZL
    PMA / PMN Number
    K033173
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN ELECTRODE FROM THE PACK OF 5 ELECTRODES WAS RETURNED FOR EVAL. THAT ELECTRODE WAS OF THE CORRECT LENGTH. FHC CHECKED ALL THE OTHER ELECTRODES IN-HOUSE OF THE SAME LOT AND CATALOG NUMBER, ALL WERE FOUND TO BE OF THE CORRECT LENGTH. FHC CONSIDERS THIS AS AN ISOLATED INCIDENT. ADD'L LOT NUMBERS: 593201, EXP DATE: 03/31/2014, DATE OF MFR: 04/08/2011. LOT #578641, EXP DATE: 11/30/2013, DATE OF MFR: 11/30/2010. LOT #567361, EXP DATE: 07/31/2013, DATE OF MFR: 08/20/2010.

    Description of Event or Problem · 1

    FHC REP REPORTED TO FHC/GNS PROCEDURAL SUPPORT SPECIALIST, AN INCIDENT WHERE AN ELECTRODE OUT OF FIVE FROM THE SAME STERILE PACKAGE WAS FOUND TO BE OF A SHORTER LENGTH THAN IT SHOULD BE. THE ELECTRODE WAS USED IN SURGERY WHICH DELAYED THE SURGERY, BUT 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. 575721

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other MICROTARGETING DRIVE SYSTEM