BEUDAMED
    FDA Adverse Event Other Summary report: N

    IONTOPHORETIC DRUG DELIVERY SYSTEM

    MDR report key: 17601 · Received October 6, 1994

    Report

    Report Number
    17601
    Event Type
    Other
    Date Received
    October 6, 1994
    Date of Event
    May 19, 1994
    Report Date
    October 5, 1994
    Manufacturer
    IOMED, INC.
    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 EXPERIENCED AN ELECTRICAL BURN ON RIGHT FOREARM WHILE USING EQUIPMENT INCLUDED IN HER OCCUPATIONAL THERAPY PROGRAM. ELECTRODE @1 WAS PLACED ON RIGHT HAND/RADIAL THUMB AREA, ELECTRODE #2 PLACED ON DORSAL RIGHT WRIST. TIMER: 2 MINUTES. OUTPUT: 2 MILLIAMPS BURN ON ELECTRODE #2, DORSAL FOREARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IONTOPHORETIC DRUG DELIVERY SYSTEM KTB IOMED, INC. PHORESOR II PM700 14498

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other