BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAGE

    MDR report key: 1855377 · Received September 30, 2010

    Report

    Report Number
    MW5017667
    Event Type
    Injury
    Date Received
    September 30, 2010
    Date of Event
    August 14, 2010
    Report Date
    September 30, 2010
    Manufacturer
    SAGE PRODUCTS INC.
    Product Code
    EFW
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    NURSE USING SAGE ORAL CARE KIT TO CLEAN ICU PT'S MOUTH. PT SEDATED AND ON MECHANICAL VENTILATION. PT BIT OFF GREEN SPONGE AT THE TIP OF THE SWAB. NURSE HAD TO RETRIEVE BROKEN OFF PORTION FROM PT'S MOUTH. POTENTIAL FOR CHOKING. PT HAD NO SIGNIFICANT ADVERSE OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAGE ORAL CARE SWAB EFW SAGE PRODUCTS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Other