BEUDAMED
    FDA Adverse Event Other Summary report: N

    IONTO TREATMENT KIT, SMALL SQUARE (12)

    MDR report key: 615071 · Received June 17, 2005

    Report

    Report Number
    2939821-2005-00004
    Event Type
    Other
    Date Received
    June 17, 2005
    Date of Event
    February 11, 2005
    Report Date
    June 16, 2005
    Manufacturer
    NORTH COAST MEDICAL, INC.
    Product Code
    EGJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT VISITED OCCUPATIONAL THERAPIST (OT), SEEKING TREATMENT FOR TENDONITIS. SMALL SQUARE IONTOPHORESIS ELECTRODE APPLIED ADJACENT TO PATIENT'S WRIST. NOTHING NOTED ON INITIAL VISIT. ON FOLLOW-UP VISIT TO OT, DAMAGED SKIN VISIBLE IN LOCATION WHERE ELECTRODE WAS USED. WAS A "FULL THICKNESS INJURY" THAT LOOKED LIKE A 3RD DEGREE BURN. PATIENT WENT TO SEE THEIR REGULAR DOCTOR FOR TREATMENT OF SKIN INJURY. DOCTOR REFERRED PATIENT TO HOSPITAL FOR WHIRLPOOL TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IONTO TREATMENT KIT, SMALL SQUARE (12) IONTOPHORESIS TREATMENT ELECTRODE EGJ NORTH COAST MEDICAL, INC. NC89250B 251478-003

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other