BEUDAMED
    FDA Adverse Event Other Summary report: N

    NORTH COAST MEDICAL

    MDR report key: 697866 · Received April 7, 2006

    Report

    Report Number
    1528764-2006-00001
    Event Type
    Other
    Date Received
    April 7, 2006
    Date of Event
    October 6, 2005
    Report Date
    March 31, 2006
    Manufacturer
    SELECTIVE MED COMPONENTS, INC.
    Product Code
    EGJ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SAME AS REPORTED BY DISTRIBUTOR, NORTH COAST MEDICAL, INC. 12/05, MFR. REPORT # 2939821-2005-00008. NOT REPORTED TO MFR SELECTIVE MED COMPONENTS, INC., UNTIL 3/06. AFTER IONTOPHORESIS TREATMENT: "SKIN IRRITATION", "REQUIRED MEDICAL TREATMENT FOR THE REACTION." NOTE: TREATMENT DOSE EXCEEDED MAXIMUM RECOMMENDED DOSAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NORTH COAST MEDICAL IONTOPHORESIS TREATMENT ELECTRODES EGJ SELECTIVE MED COMPONENTS, INC. NC89255B 050620-800

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention