BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SODASORB LF

    MDR report key: 1242823 · Received October 30, 2008

    Report

    Report Number
    1242823
    Event Type
    Malfunction
    Date Received
    October 30, 2008
    Date of Event
    October 30, 2008
    Report Date
    October 30, 2008
    Manufacturer
    WR GRACE & COMPANY
    Product Code
    BSF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VT, US

    Narratives

    Description of Event or Problem · 1

    CRNA REPORTED THAT CONTAINERS OF SODASORB LF (CO2 ABSORBENT) ARRIVE WITH PARTIAL COLOR CHANGE OR SUBSTANTIAL COLOR CHANGE, INDICATING ABSORPTION OF CO2 FROM AMBIENT AIR. ABSORBENT DUST COMING THROUGH BOTTOM OF PLASTIC WRAP INDICATES EXISTENCE OF ONE OR MORE PIN HOLES IN PLASTIC FILM WRAP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SODASORB LF ABSORBER, CARBON DIOXIDE BSF WR GRACE & COMPANY * CV07-P128

    Patients

    Seq Age Sex Outcome Treatment
    1 *