BEUDAMED
    FDA Adverse Event Other Summary report: N

    THERMOGARD ADULT DUAL DISPERSIVE ELECTRODE

    MDR report key: 2721709 · Received August 30, 2012

    Report

    Report Number
    1320894-2012-00060
    Event Type
    Other
    Date Received
    August 30, 2012
    Date of Event
    July 1, 2012
    Report Date
    October 24, 2012
    Manufacturer
    CONMED CORPORATION
    Product Code
    GEI
    PMA / PMN Number
    K972628
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT DEVICE HAS BEEN DISCARDED BY THE END-USER AND IS NOT AVAILABLE FOR EVALUATION. PICTURES OF THE DEVICES AND OF THE "SKIN IRRITATION" ARE AVAILABLE AND HAVE BEEN FORWARDED BY THE DISTRIBUTOR TO CONMED CORPORATION. WHEN THE QUALITY ENGINEERING INVESTIGATION IS COMPLETED A SUPPLEMENTAL REPORT WILL BE SUBMITTED. SUSPECT DEVICES NOT BEING RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED, "THE PATIENT'S SKIN DEVELOPED REDNESS AFTER USING THE GROUND PAD. THE HOSPITAL FOUND IT EIGHT DAYS AFTER C-SECTION. SHE WAS INFLAMED BY AN ALLERGIC REACTION TO INSTILLATION SITE OF TOCOLYSIS UTEMERIN IN THE HOSPITAL WITH THREATENED PREMATURE LABOR. THE HOSPITAL'S DERMATOLOGIST SAID, SHE WAS INFLAMED BY AN ALLERGIC REACTION TO CONTACT WITH FOREIGN MATERIAL OVER A LONG TIME BECAUSE SHE HAD HAD NON-ALLERGIC REACTION TO THE NEEDLE FOR BLOOD COLLECTION. AND SHE HAS METALLIC ALLERGY." THE HOSPITAL'S DERMATOLOGIST REQUESTED THE RAW MATERIALS OF THE DISPERSIVE ELECTRODE FOR PATCH TESTING OF THIS PATIENT. A PRODUCT SPECIFICATION SHEET WAS PROVIDED TO THE DISTRIBUTOR TO FORWARD TO THE HOSPITAL DERMATOLOGIST. PICTURES PROVIDED EXHIBIT THE RED SKIN IRRITATION UNDER THE DISPERSIVE ELECTRODE AS WELL AS THE THERMOGARD DISPERSIVE ELECTRODE HELD NEXT TO THE SKIN IRRITATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERMOGARD ADULT DUAL DISPERSIVE ELECTRODE DISPERSIVE ELECTRODE GEI CONMED CORPORATION UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other