BEUDAMED
    FDA Adverse Event Other Summary report: N

    NEWMARK PAINMASTER MCT PATCH

    MDR report key: 1525950 · Received November 10, 2009

    Report

    Report Number
    1226514-2009-00001
    Event Type
    Other
    Date Received
    November 10, 2009
    Date of Event
    October 23, 2009
    Report Date
    November 2, 2009
    Manufacturer
    NEWMARK, INC.
    Product Code
    LBF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS AN EXTREMELY UNUSUAL EVENT. NEWMARK HAS BEEN MARKETING AND DISTRIBUTING MICRO CURRENT PRODUCT FOR SEVERAL YEARS. WE HAVE NEVER RECEIVED A REPORT OF THIS TYPE NOR HAS ANY OF OUR TESTING OR EVALS SUGGESTED SIMILAR CONDITIONS EXPERIENCED BY THE PT. THE DEVICE WAS NOT RETURNED AND WE CANNOT DETERMINE THE CAUSE OF THIS EVENT.

    Description of Event or Problem · 1

    CONSUMER ALLEGED THAT WHILE USING THE MCT MICRO CURRENT PATCH, HE DEVELOPED A METALLIC TASTE IN HIS MOUTH AND FELT LIKE THE BLOOD VESSELS IN HIS HEAD WERE "POUNDING" AND FELT LIGHTHEADED. THERE WERE NO REPORTED PT INJURIES AND THE PT REPORTED THAT THE SYMPTOMS DISAPPEARED AFTER REMOVING THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEWMARK PAINMASTER MCT PATCH TENS, MICROCURRENT NERVE STIMULATOR LBF NEWMARK, INC. 7500 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other