BEUDAMED
    FDA Adverse Event Other Summary report: N

    5500 Q-TRACE GOLD 100/P/2000/C

    MDR report key: 1781435 · Received July 29, 2010

    Report

    Report Number
    1219103-2010-00009
    Event Type
    Other
    Date Received
    July 29, 2010
    Date of Event
    June 17, 2010
    Report Date
    July 7, 2010
    Manufacturer
    COVIDIEN
    Product Code
    DRX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: (B)(4) 2010. 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)(6) 2010 THAT A CUSTOMER HAD AN ISSUE WITH THE Q-TRACE GOLD ELECTRODES. THE CUSTOMER REPORTED THAT SHE HAD A SKIN REACTION AFTER THE USE OF THE ELECTRODES WHILE RECEIVING MEDICAL ATTENTION AT A HOSPITAL. WHEN SHE RETURNED HOME, SHE OBSERVED A RAISED RED BLISTERING RASH WHERE THE ELECTRODES HAD BEEN PLACED, SHE USED BENADRYL FOR ONE WEEK THEN SOUGHT MEDICAL ATTENTION FROM HER PHYSICIAN. HER PHYSICIAN PRESCRIBE PREDNISONE TO BE TAKEN OVER A SEVEN DAY PERIOD. PT REPORTS SHE IS DOING BETTER AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5500 Q-TRACE GOLD 100/P/2000/C ELECTRODES DRX COVIDIEN 30807732 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other