BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNK ELECTRODE

    MDR report key: 3142243 · Received May 24, 2013

    Report

    Report Number
    1219103-2013-00026
    Event Type
    Other
    Date Received
    May 24, 2013
    Date of Event
    April 25, 2013
    Report Date
    April 30, 2013
    Manufacturer
    COVIDIEN
    Product Code
    GXY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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) 2013 THAT A CUSTOMER HAD AN ISSUE WITH AN ELECTRODE. THE CUSTOMER REPORTS THAT HE WAS IN THE EMERGENCY ROOM AT (B)(6) AND HAD COVIDIEN ECG ELECTRODES PUT ON HIS BODY, ON (B)(6) AT 3:00 PM. THE ELECTRODES WERE NOT REMOVED UNTIL (B)(6) AT 4:00 PM WHEN HE WAS RELEASED FROM THE EMERGENCY DEPARTMENT. UPON REMOVAL OF THE ELECTRODES, THERE WAS AN EXTREMELY ROUGH, STRINGY GLUE THAT HELD THEM IN PLACE. SOME OF THE CONTACTS WERE STILL FOUND ON (B)(6) WHEN HE WAS HOME; HE THEN REMOVED THREE UNDER HIS LEFT BREAST, AND ONE ON EACH ANKLE. THERE WERE RECTANGULAR MARKS ON HIS SKIN WHICH WERE EXTREMELY ITCHY AND ON (B)(6) NIGHT HE NOTICED THAT THE ONE ON HIS RIGHT SHOULDER LOOKED LIKE A SHINGLES PUSTULE. WHEN HE GOT UP ON (B)(6,) THE RECTANGLE HAD FILLED IN WITH FOUR MORE PUSTULES. HE WENT STRAIGHT TO THE MEDICAL CLINIC WHERE HE WAS GIVEN ANTI-VIRAL MEDICATION FOR SHINGLES BECAUSE HE KNEW THAT IT MUST BE ADMINISTERED WITHIN 72 HOURS TO STOP SHINGLES. HE SAW HIS OWN DOCTOR ON (B)(6). THE DOCTOR SAID IT WAS CONTACT DERMATITIS AND GAVE HIM BETADERM 0.1% (BETAMETASON VALERATE) TO TREAT THE SKIN IRRITATION. HE CONTINUED WITH THE SHINGLES MEDICATION FOR THE DURATION OF THE PRESCRIPTION. EACH SPOT VISUALLY BECAME MORE RED AND ITCHED QUITE BADLY FOR THE NEXT 7 - 10 DAYS. THE MARKS ON HIS ANKLES, WHERE THERE WAS LESS SOFT TISSUE, BURNED TO THE POINT THAT YOU COULD ACTUALLY SEE THE FASCIA ON THE UNDERLYING TISSUE. BOTH ANKLES NOW HAVE PERFECTLY RECTANGULAR MARKS. THE SPOTS ON HIS STOMACH AND SHOULDERS HAVE COME DOWN TO JUST PINK RECTANGLES BUT WERE QUITE RED AND ITCHY FOR 10 DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231948 UNK ELECTRODE ELECTRODE GXY COVIDIEN UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other