BEUDAMED
    FDA Adverse Event Summary report: N

    COROMETRICS

    MDR report key: 175173 · Received June 30, 1998

    Report

    Report Number
    175173
    Date Received
    June 30, 1998
    Date of Event
    May 22, 1998
    Report Date
    May 27, 1998
    Manufacturer
    COROMETRICS MED SYSTEMS
    Product Code
    DRX
    Report Source
    User Facility report
    Reporter Location
    KY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    YELLOWISH FLD. FILLED BLISTER NOTED UNDER ELECTRODE LEAD (RIGHT-SIDE, WHITE LEAD) (1.5 CM X .5 CM) CONNECTED TO 2 515A H/A MONITOR. ELECTRODE - NEOTRODE II BACITRACIN TO LESION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COROMETRICS H/A MONITOR DRX COROMETRICS MED SYSTEMS 515A/MONITOR 802045-05/ELECTRODE

    Patients

    Seq Age Sex Outcome Treatment
    1 12 DAY