BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPIRO

    MDR report key: 23107157 · Received September 22, 2025

    Report

    Report Number
    3014054118-2025-00001
    Event Type
    Injury
    Date Received
    September 22, 2025
    Date of Event
    March 31, 2025
    Report Date
    September 17, 2025
    Manufacturer
    FOGLESS INTERNATIONAL AB
    Product Code
    JOH
    PMA / PMN Number
    K122932
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT DID NOT INVOLVE A MALFUNCTION OF THE SPIRO SPEAKING VALVE. THE USER FAILED TO FOLLOW THE MANUFACTURER'S LABELLING, INCLUDING A CAUTION SYMBOL PRINTED ON THE DEVICE, AND THE BOLD WARNING TEXT IN THE INSTRUCTIONS FOR USE "NEVER PLACE A SPEAKING VALVE ON A TRACHEAL CANNULA THAT HAS AN INFLATED CUFF AND IS NOT FENESTRATED".

    Description of Event or Problem · 0

    THE PATIENT HAS PRESENTED TO AN OPERATION WITH A TRACHEOSTOMY CANNULA THAT ALLOWED EXHALATION PAST AND/OR THROUGH THE CANNULA AND WAS COMPATIBLE WITH THE SAFE USE OF A SPEAKING VALVE AT THAT TIME. IN THIS CASE IT WAS BRIGHTLY COLOURED PINK SPIRO 710R SPEAKING VALVE (ONE WAY VALVE). DURING THE OPERATION, A NEW CANNULA WAS INTRODUCED INTO THE PATIENT, AND SOMETIME AFTER THIS THE SPEAKING VALVE WAS RETURNED. IT WAS AT THIS STAGE THE PATIENT COULD NOT BREATHE OUT PAST AND/OR THROUGH THE CANNULA, WHICH THUS LED TO A SEVERE DETERIORATION IN HEALTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2656194 SPIRO SPEAKING VALVE WITH OXYGEN NIPPLE JOH FOGLESS INTERNATIONAL AB 710R 5570

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| L