BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULMOGUARD DISPOSABLE BACTERIAL/VIRAL FILTER MOUTHPIECE

    MDR report key: 27925 · Received November 7, 1995

    Report

    Report Number
    MW1007601
    Event Type
    Malfunction
    Date Received
    November 7, 1995
    Date of Event
    October 25, 1995
    Report Date
    October 26, 1995
    Manufacturer
    SDI DIAGNOSTICS, INC.
    Product Code
    CAH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING PULMONARY TESTING PT INHALED, BUT DID NOT ASPIRATE, PART OF THE PLASTIC MOUTHPIECE, BUT DID SPIT OUT A PIECE OF IT. THE MOUTHPIECE HAD ACTUALLY FRACTURED INTO 3 PIECES SMALLER THAN 2 CM EACH. THIS COULD HAVE EASILY BEEN ASPIRATED. THE NEXT DAY A DIFFERENT MOUTHPIECE WAS USED BY PULMONARY DIR AND SHE ALSO DID NOT BITE HARD BUT WHEN PLACING TEETH AND LIPS AROUND MOUTHPIECE SHE HEARD MOUTHPIECE CRACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULMOGUARD DISPOSABLE BACTERIAL/VIRAL FILTER MOUTHPIECE BACTERIAL/VIRAL FILTER MOUTHPIECE CAH SDI DIAGNOSTICS, INC. 34764

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other