BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IONTOPHORESIS PADS

    MDR report key: 2450216 · Received February 9, 2012

    Report

    Report Number
    MW5024211
    Event Type
    Malfunction
    Date Received
    February 9, 2012
    Date of Event
    January 12, 2012
    Manufacturer
    NORTH COAST MEDICAL, INC.
    Product Code
    EGJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AFTER USING NORCO ELECTRODES, PATIENT PRESENTED WITH RESIDUAL SMALL REDDENED BURN AREA ON FOREARM WHERE PAD HAD BEEN PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IONTOPHORESIS PADS EGJ NORTH COAST MEDICAL, INC. NC89255B

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR