BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PORTEX

    MDR report key: 11090281 · Received December 29, 2020

    Report

    Report Number
    3012307300-2020-12825
    Event Type
    Injury
    Date Received
    December 29, 2020
    Date of Event
    November 18, 2020
    Report Date
    December 29, 2020
    Manufacturer
    SMITHS MEDICAL INTERNATIONAL, LTD.
    Product Code
    BTO
    UDI-DI
    15019315107207
    PMA / PMN Number
    K083031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INFORMATION RECEIVED A SMITHS MEDICAL TRACHEOSTOMY/PVC - PORTEX TUBES PDT UNIPERC HAD CUFF FAILURE DURING AN AIRWAY EMERGENCY. TRACHEOSTOMY TUBE WAS REMOVED AND THE PATIENT WAS INTUBATED FROM ABOVE. NO FURTHER INFORMATION AVAILABLE ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1554957 PORTEX TRACHEOSTOMY BTO SMITHS MEDICAL INTERNATIONAL, LTD. 100/897/080CZ 3986061 15019315107207

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention