BEUDAMED
    FDA Adverse Event Other Summary report: N

    530 MEDI-TRACE FM 30/PK 600/CA

    MDR report key: 3736620 · Received April 2, 2014

    Report

    Report Number
    9681860-2014-00004
    Event Type
    Other
    Date Received
    April 2, 2014
    Report Date
    March 18, 2014
    Manufacturer
    COVIDIEN
    Product Code
    DRX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(4) 2014 THAT A CUSTOMER HAD AN ISSUE WITH AN ELECTRODE. THE CUSTOMER REPORTS THAT THEY HAD A PT WHO EXPERIENCED FAIRLY SERIOUS SKIN DAMAGE, POSSIBLE BURNS, WHILE USING THIS PRODUCT. THE PT WAS SEEN IN THE EMERGENCY DEPARTMENT IMMEDIATELY. THE PT WAS PRESCRIBED HYDERM CREAM 1 PERCENT BY THE PHYSICIAN HE SAW IN THE EMERGENCY ROOM ON (B)(6) 2014. BLISTERING, OOZING, REDNESS, WERE ALL NOTED ON THE PT'S SKIN AND IT WAS VERY PAINFUL. THE CUSTOMER FURTHER REPORTS THAT THE NURSES NOTES FROM THE EMERGENCY ROOM STATE: 2 NOTICEABLE RED BURNS FROM LEAD STICKERS. AREA PAINFUL ICE PACKS, NO DRAINAGE. THE DOCTORS NOTES STATE DESQUAMATED WELL DEMARCATED ERYTHEMATOUS LESION X 7 ON CHEST AND RIBS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199843 530 MEDI-TRACE FM 30/PK 600/CA ELECTRODES DRX COVIDIEN 31013926 319707X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other