BEUDAMED
    FDA Adverse Event Other Summary report: N

    IONTOPHORESIS TREATMENT KIT, MEDIUM SQUARE

    MDR report key: 622615 · Received July 21, 2005

    Report

    Report Number
    2939821-2005-00006
    Event Type
    Other
    Date Received
    July 21, 2005
    Date of Event
    June 1, 2005
    Report Date
    July 20, 2005
    Manufacturer
    NORTH COAST MEDICAL, INC.
    Product Code
    EGJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT GIVEN TREATMENT BY PHYSICAL THERAPIST (PT) ON CALF OF LEG WITH DEVICE. AFTER INITIAL PHYSICAL THERAPY SESSION, COMPLAINED TO PT OF RASH ON TREATMENT LOCATION (CALF).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IONTOPHORESIS TREATMENT KIT, MEDIUM SQUARE IONTOPHORESIS TREATMENT ELECTRODE EGJ NORTH COAST MEDICAL, INC. NC89251B 251343-003 RETURN

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other