BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOSCA 500 USA

    MDR report key: 5067265 · Received September 8, 2015

    Report

    Report Number
    1523456-2015-00001
    Event Type
    Injury
    Date Received
    September 8, 2015
    Date of Event
    August 5, 2015
    Report Date
    August 5, 2015
    Manufacturer
    RADIOMETER AMERICA, INC.
    Product Code
    DQA
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHEN THEY REMOVED THE ELECTRODE IT APPEARED AS IF IT "REMOVED A LAYER OF SKIN FROM THE PATIENT" AND ELABORATED BY STATING THAT IT WAS A PERFECT CIRCLE THE SIZE OF THE INTERNAL DIAMETER OF THE FIXATION RING. THE CUSTOMER STATED THAT IT WAS "LIKELY A BURN". THE EVENT OCCURRED ON (B)(6) 2015. THE MONITOR TEMPERATURE WAS NOTED AT 44 DEGREES CELSIUS. THE CUSTOMER EXPLAINED THAT THIS MONITOR WAS USED FOR SLEEP STUDIES THAT CAN LAST UP TO 10 HOURS, AND THAT THE SITE TIME WAS SET AT 9 HOURS. REFERENCE MFR # 3002807968-2015-00021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592979 TOSCA 500 USA TOSCA 500 USA MONITOR DQA RADIOMETER AMERICA, INC. TOSCA 500

    Patients

    Seq Age Sex Outcome Treatment
    1