BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX

    MDR report key: 12508597 · Received September 21, 2021

    Report

    Report Number
    3012307300-2021-09504
    Event Type
    Malfunction
    Date Received
    September 21, 2021
    Date of Event
    June 12, 2020
    Report Date
    September 21, 2021
    Product Code
    JOH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED INDICATING THAT PRIOR TO OPERATION, THE BALLOON OF A SMITHS MEDICAL TRACHEOSTOMY/PVC - PORTEX TUBES PDT GRIGG CANNULA WAS NOT ABLE TO BE INFLATED. IT WAS ALSO REPORTED THAT AFTER PLACING THE CANNULA ON THE PATIENT, THE BALLOON CANNOT BE INFLATED, AND A LEAK WAS FOUND IN THE BALLOON WHEN IT WAS REMOVED AND CHECKED. NO ADVERSE EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1405716 PORTEX TRACHEOSTOMY TUBE AND TUBE CUFF JOH 3710322

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR