BEUDAMED
    FDA Adverse Event Other Summary report: N

    530 MEDI-TRACE FM 30/PK 600/CA

    MDR report key: 3736610 · Received April 1, 2014

    Report

    Report Number
    9681860-2014-00003
    Event Type
    Other
    Date Received
    April 1, 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, POSSIBLY BURNS WHILE USING THIS PRODUCT. THE PT VISITED THE FAMILY DOCTOR ON DAY 3 AND WAS SEEN IN THE EMERGENCY DEPARTMENT ON DAY 6/7 DUE TO POOR HEALING. THE CUSTOMER REPORTS THE PT USED A CORTISONE OINTMENT AND STOPPED USING IT AFTER 3 DAYS BECAUSE OF NO EFFECT. SHE SWITCHED TO AN OVER THE COUNTER ANTIBIOTIC (POLYSPORIN) OINTMENT, OTHERWISE, JUST A CLEAN GAUZE DRESSING. THE CUSTOMER FURTHER REPORTS SKIN PREP WAS WITH ALCOHOL, TRACE PREP (STRIP SANDPAPER). THE CUSTOMER FURTHER REPORTS THE PT HAD THE HOLTER MONITOR REMOVED ON (B)(6) 2014. THE PT SAW THE DOCTOR ON (B)(6) 2014 AND WAS PRESCRIBED BETADERM. THE BETADERM DID NOT HELP AND THE PT DISCONTINUED USE AFTER A COUPLE OF DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196662 530 MEDI-TRACE FM 30/PK 600/CA ELECTRODE DRX COVIDIEN 31013926 319707X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other