BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEN20 CONDUCTIVE PASTE

    MDR report key: 2489557 · Received March 6, 2012

    Report

    Report Number
    1718791-2012-00002
    Event Type
    Injury
    Date Received
    March 6, 2012
    Date of Event
    February 3, 2012
    Report Date
    March 5, 2012
    Manufacturer
    D.O. WEAVER AND COMPANY
    Product Code
    GYB
    PMA / PMN Number
    K883149
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTER HAS BEEN OUT OF THE OFFICE FOR A FEW WEEKS AND HAS BEEN UNABLE TO GIVE US ADDITIONAL INFO AS TO THE CURRENT CONDITION OF THE PT. WE WILL CONTINUE TO FOLLOW UP WITH HER, BUT AS OUR 30-DAY FILING DEADLINE IS APPROACHING, WE WILL SIMPLY HAVE TO REPORT WHAT WE KNOW AT THIS TIME. IT IS NOT UNCOMMON FOR A PT TO HAVE SOME HAIR LOSS AFTER ELECTRODES HAVE BEEN STUCK TO THE SCALP FOR AN EXTENDED PERIOD OF TIME. WE ALSO KNOW THAT THE PT IS ON A LONG LIST OF MEDICATIONS, MANY OF WHICH ARE KNOWN TO ALSO CAUSE HAIR LOSS. MOST LIKELY IT IS A COMBINATION OF THE ELECTRODE PASTE, THE TREATMENT HER BEAUTICIAN DOES ON HER HAIR, AND THE MEDICATIONS THAT SHE IS ON WHICH HAS CONTRIBUTED TO HER HAIR LOSS. PT CURRENTLY TAKING THE FOLLOWING MEDICATIONS: ESTRADIOL, SYNTHROID, METFORMIN, LIPITOR, OMEPRAZOLE, CYMBALTA, LEVEMIR SUBQ, NOVOLOG FLEXPEN, LAMICTAL, MECLIZINE, SPIRONOLACTONE, TORSEMIDE, ASPIRIN, PHENYTOIN, DOCUSATE SODIUM, ALBUTEROL, LOSARTAN, COREG, NITROSTAT, SAPHRIS.

    Description of Event or Problem · 1

    PT REPORTED HAIR LOSS AFTER A SLEEP STUDY WAS CONDUCTED ON HER. SLEEP STUDY COMPLETED (B)(6) 2012, PT WENT TO BEAUTICIAN ON (B)(6) 2012 TO GET THE REMAINING PASTE REMOVED FROM HER HAIR. ACCORDING TO THE PT, EVERYWHERE THERE WAS PASTE, THERE WAS ALSO HAIR LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TEN20 CONDUCTIVE PASTE TEN20 PASTE GYB D.O. WEAVER AND COMPANY UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other