BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INHEALTH TOTAL VOICE PROSTHESIS

    MDR report key: 2881675 · Received December 17, 2012

    Report

    Report Number
    MW5028228
    Event Type
    Injury
    Date Received
    December 17, 2012
    Date of Event
    October 23, 2012
    Report Date
    November 20, 2012
    Manufacturer
    IN HEALTH TECHNOLOGIES
    Product Code
    EWL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PATIENT IN ENT CLINIC FOR ROUTINE CHANGE OF TOTAL VOICE PROSTHESIS BY SPEECH THERAPIST. DEVICE CHANGED AND SPEECH THERAPIST NOTED THAT THE VALVE DOOR OF NEW DEVICE HAD DETACHED FROM THE PROSTHESIS AND WAS LYING ON THE POSTERIOR WALL OF THE PT'S TRACHEA. ENT ATTENDING PHYSICIAN WAS ABLE TO IMMEDIATELY REMOVE THE VALVE DOOR WITH A FLEXIBLE LARYNGOSCOPE AND SUCTION APPARATUS. THE PT SUFFERED NO INJURY. A VOICE PROSTHESIS FROM A DIFFERENT MFR WAS REPLACED IN THE PT. THE CHIEF OF AUDIOLOGY AND SPEECH PATHOLOGY NOTIFIED THE COMPANY OF THE EVENT. DATES OF USE: (B)(6) 2012. REASON FOR USE: LARYNGECTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INHEALTH TOTAL VOICE PROSTHESIS TEP EWL IN HEALTH TECHNOLOGIES 16FR/6MM 1030667

    Patients

    Seq Age Sex Outcome Treatment
    1