BEUDAMED
    FDA Adverse Event Other Summary report: N

    NORTH COAST MEDICAL

    MDR report key: 633194 · Received August 30, 2005

    Report

    Report Number
    1528764-2005-00003
    Event Type
    Other
    Date Received
    August 30, 2005
    Date of Event
    January 1, 2005
    Report Date
    August 30, 2005
    Manufacturer
    SELECTIVE MED COMPONENTS INC.
    Product Code
    EGJ
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    SAME AS ORIGINALLY REPORTED BY USER-HOSPITAL REPORT# 3901160000-2005-8003 "RASH AT THE SITE WHERE THE ELECTRODES HAD BEEN APPLIED".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NORTH COAST MEDICAL BUFFERED IONTOPHORESIS ELECTRODE EGJ SELECTIVE MED COMPONENTS INC. * RETURN 251343-003

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other