BEUDAMED
    FDA Adverse Event Other Summary report: N

    ECG NEONATAL ELECTRODE W/LEADWIRES

    MDR report key: 517357 · Received March 23, 2004

    Report

    Report Number
    1317214-2004-00016
    Event Type
    Other
    Date Received
    March 23, 2004
    Date of Event
    February 23, 2004
    Report Date
    February 24, 2004
    Manufacturer
    CONMED CORP
    Product Code
    DRX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    "IT WAS REPORTED THAT" THE PT WAS FOUND TO HAVE FLUID FILLED BLISTERS UNDER THE LOWER MONITOR LEADS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECG NEONATAL ELECTRODE W/LEADWIRES CONMED ECG NEONATAL ELECTRODE W/LEADWIRES DRX CONMED CORP NA 0307021

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other