BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUMIDAIRE 3I - AMERICAS

    MDR report key: 1586918 · Received January 20, 2010

    Report

    Report Number
    3004604967-2010-00004
    Event Type
    Injury
    Date Received
    January 20, 2010
    Date of Event
    October 18, 2009
    Report Date
    January 20, 2010
    Manufacturer
    RESMED LTD.
    Product Code
    BTT
    PMA / PMN Number
    K013843
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THIS EVENT IS NOT ALLEGED TO BE FAULTY AND WAS NOT RETURNED TO RESMED FOR INVESTIGATION. THE PATIENT INFORMED RESMED THAT THEY FELL OUT OF THEIR BED AND ONTO THEIR HUMIDIFIER AND CUT THEIR CHIN. THE CUT REQUIRED STITCHES.

    Description of Event or Problem · 1

    A PATIENT REPORTED TO RESMED THAT THEY CUT THEIR CHIN BY FALLING OUT OF THEIR BED AND ONTO THEIR CPAP HUMIDIFIER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUMIDAIRE 3I - AMERICAS HUMIDAIRE 3I BTT RESMED LTD. 33906

    Patients

    Seq Age Sex Outcome Treatment
    1