BEUDAMED
    FDA Adverse Event Summary report: N

    PROVOX LARYTUBE 9/36, FENESTRATED

    MDR report key: 6127383 · Received November 25, 2016

    Report

    Report Number
    8032044-2016-00012
    Date Received
    November 25, 2016
    Date of Event
    October 27, 2016
    Report Date
    November 25, 2016
    Manufacturer
    ATOS MEDICAL AB
    Product Code
    KAC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    SPEECH THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS BEING SHIPPED FROM US TO (B)(6) FOR INVESTIGATION. I WILL FOLLOW UP ON THIS INITIAL REPORT WHEN THE DEVICE HAS BEEN INVESTIGATED. KIND REGARDS, (B)(6) ATOS MEDICAL AB.

    Description of Event or Problem · 1

    THIS IS THE INFORMATION THAT WAS RECEIVED FROM THE ATOS MEDICAL LOCAL REPRESENTATIVE: THE PATIENT REPORTED TO THE CLINICIAN FOR A PROSTHESIS PLACEMENT AND NOTIFIED THE SLP THAT HE WAS CONCERNED THAT HE COULD NOT FIND HIS LARYTUBE AND THOUGHT HE SWALLOWED IT. UPON INSPECTION, IT APPEARED THAT THE TUBE WAS LODGED IN HIS TRACHEA. DR. (B)(6) REMOVED THE LARYTUBE WITHOUT DIFFICULTY AND IT APPEARED THAT THE PATIENT REMOVED THE LARGER PART OF THE LARYTUBE THAT IS INTENDED TO PREVENT ASPIRATION OF THE TUBE AND HOUSE THE HME. UPON REMOVAL, THERE WAS NO EVIDENCE OF DISTRESS. THE SURGEON, MYSELF (B)(6) TOLD THE PATIENT THAT YOU ARE NOT TO REMOVE THE OUTER PORTION OF THE TUBE AND HE STATED UNDERSTANDING. THE DAMAGED DEVICE IS AVAILABLE AND WILL BE SENT FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    778116 PROVOX LARYTUBE 9/36, FENESTRATED PROVOX LARYTUBE KAC ATOS MEDICAL AB

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention