BEUDAMED
    FDA Adverse Event Other Summary report: N

    NEOTRODE II - O

    MDR report key: 218002 · Received April 7, 1999

    Report

    Report Number
    218002
    Event Type
    Other
    Date Received
    April 7, 1999
    Date of Event
    February 24, 1999
    Report Date
    March 4, 1999
    Manufacturer
    CONMED
    Product Code
    DRX
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    REMOVED NEONATAL ECG ELECTRODE FROM SKIN. BLISTER NOTED APPROX 6 MM X 4 MM W/FLUID FILLED AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEOTRODE II - O ELECTRODE LEAD DRX CONMED * *

    Patients

    Seq Age Sex Outcome Treatment
    1 8 DAY Other