BEUDAMED
    FDA Adverse Event Other Summary report: N

    MICROPAQ

    MDR report key: 547916 · Received October 8, 2004

    Report

    Report Number
    3023750-2004-00015
    Event Type
    Other
    Date Received
    October 8, 2004
    Date of Event
    August 26, 2004
    Report Date
    October 6, 2004
    Manufacturer
    WELCH ALLYN PROTOCOL, INC.
    Product Code
    MWI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT WAS ADMITTED FOR PLACEMENT OF A CARDIAC PACEMAKER (LEFT UPPER CHEST) IN 04. PT EXPERIENCED DISCOMFORT IN THE RIGHT UPPER CHEST AREA, IMMEDIATELY BELOW THE R NIPPLE. NURSE RESPONDED WITHIN 5 MINUTES AND OBSERVED A 1ST DEGREE BURN IN THE AREA IDENTIFIED. CUSTOMER STATED THAT THE "PT IS FINE AND DOES NOT REQUIRE FOLLOW-UP."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROPAQ PHYSIOLOGIC MONITOR FOR ECG AND SPO2 MONITORING MWI WELCH ALLYN PROTOCOL, INC. 402 *

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other