BEUDAMED
    FDA Adverse Event Other Summary report: N

    IONTOPHORESIS TREATMENT KIT

    MDR report key: 635094 · Received September 14, 2005

    Report

    Report Number
    2939821-2005-00007
    Event Type
    Other
    Date Received
    September 14, 2005
    Date of Event
    August 23, 2005
    Report Date
    September 14, 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

    PATIENT REC'D IONTOPHORESIS TREATMENT WITH DEXAMETHASONE BY PHYSICAL THERAPIST (PT) ON RIGHT SHOULDER/ARM. NO REDNESS IMMEDIATELY AFTER TREATMENT. 4 HOURS LATER, PT CALLED AND STATED THAT THEY HAD A HOLE IN THEIR ARM. THE FOLLOWING DAY, PT REC'D TREATMENT FROM PT FOR INCIDENT. THERAPIST NOTED MINOR SKIN BREAKDOWN ON RIGHT BICEP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IONTOPHORESIS TREATMENT KIT IONTOPHORESIS TREATMENT ELECTRODE EGJ NORTH COAST MEDICAL, INC. * 4308-1

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other