BEUDAMED
    FDA Adverse Event Other Summary report: N

    IOTRODE PAD

    MDR report key: 56880 · Received December 13, 1996

    Report

    Report Number
    56880
    Event Type
    Other
    Date Received
    December 13, 1996
    Date of Event
    June 3, 1996
    Report Date
    June 10, 1996
    Manufacturer
    HENLEY DIV.
    Product Code
    KTB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT RECEIVED IONTOPHORESIS TREATMENT TO BILATERAL ANTERIOR SHOULDERS, 2 SMALL BURNS WERE NOTED ONE OVER EACH ANTERIOR SHOULDER AT LOCATION OF ELECTRODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IOTRODE PAD IOTRODE ELECTRODE KTB HENLEY DIV. * HWC

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other