BEUDAMED
    FDA Adverse Event Other Summary report: N

    NA

    MDR report key: 80476 · Received March 26, 1997

    Report

    Report Number
    80476
    Event Type
    Other
    Date Received
    March 26, 1997
    Date of Event
    November 5, 1996
    Report Date
    November 13, 1996
    Manufacturer
    INVIVO RESEARCH
    Product Code
    DSA
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BLISTERS/WELTS UNDER 3 OF 4 ECG PATCHES NOTED FOLLOWING MRI OF RT SHOULDER. PT MONITORED UNDER ANESTHESIA. DEVICES FUNCTIONED CORRECTLY. LAST PM 4/96.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NA ECG 4 LEAD CABLE DSA INVIVO RESEARCH 9239 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other ECG CABLE 9204,| ECG PATCHES 3M RED DOT # 2239| OMNITRACK 3100 VITAL SIGN MONITOR,