BEUDAMED
    FDA Adverse Event Other Summary report: N

    IONTOPHORESIS TREATMENT KIT, BUTTERFLY (12)

    MDR report key: 656042 · Received December 21, 2005

    Report

    Report Number
    2939821-2005-00008
    Event Type
    Other
    Date Received
    December 21, 2005
    Date of Event
    October 6, 2005
    Report Date
    December 20, 2005
    Manufacturer
    SELECTIVE MED COMPONENTS INC.
    Product Code
    EGJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT RECEIVED IONTOPHORESIS TREATMENT BY PHYSICAL THERAPIST (PT). TREATMENT GIVEN ON ANKLE FOR A LIGAMENT SPRAIN. PT DEVELOPED BLISTERING AND REDNESS AFTER TREATMENT. WITHIN 1 WEEK, PT WAS TREATED AGAIN ON ANKLE. REACTION WAS THE SAME. PT NOTED THAT TREATMENT DOSAGE EXCEEDED MAXIMUM RECOMMENDED DOSE OF 40MA-MIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IONTOPHORESIS TREATMENT KIT, BUTTERFLY (12) IONTOPHORESIS TREATMENT ELECTRODES EGJ SELECTIVE MED COMPONENTS INC. NC89255B 050620-800

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other