BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNK

    MDR report key: 168423 · Received May 18, 1998

    Report

    Report Number
    MW1013857
    Event Type
    Other
    Date Received
    May 18, 1998
    Date of Event
    July 27, 1992
    Report Date
    April 15, 1998
    Manufacturer
    ANDOVER MEDICAL, INC.
    Product Code
    DSA
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORT FROM ATTORNEY STATES THAT INFANT PT ON HEART/LUNG MONITOR WAS ALLEGEDLY INJURED WHEN ELECTROCARDIOGRAPH LEAD WIRES WERE ATTACHED TO ELECTRICAL SOURCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK ECG LEAD WIRE DSA ANDOVER MEDICAL, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other