BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 8663110 · Received June 3, 2019

    Report

    Report Number
    1218950-2019-03660
    Event Type
    Malfunction
    Date Received
    June 3, 2019
    Report Date
    May 16, 2019
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    DRY
    UDI-DI
    20884838006793
    PMA / PMN Number
    K900682
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE GEL SEPARATED FROM THE ELECTRODE, THE CHILD PUT THE GEL INTO HIS MOUTH. THERE WAS NO REPORTED PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    454984 NA SQUARE PREATTACHED LEADWIRE ELECTRODE DRY PHILIPS MEDICAL SYSTEMS 13953B 805441 2019-08-28 20884838006793

    Patients

    Seq Age Sex Outcome Treatment
    1