BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INHEALTH SPEAKING VALVE

    MDR report key: 4019635 · Received August 12, 2014

    Report

    Report Number
    4019635
    Event Type
    Malfunction
    Date Received
    August 12, 2014
    Date of Event
    July 30, 2014
    Report Date
    August 12, 2014
    Manufacturer
    INTERNATIONAL HEALTH TECHNOLOGIES
    Product Code
    EWL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US

    Narratives

    Description of Event or Problem · 1

    SPEAKING VALVE WAS PLACED APPROXIMATELY 2 MONTHS AGO. PATIENT CALLED WITH COMPLAINTS OF "LEAKING ISSUES" APPROXIMATELY 6 WEEKS AFTER SPEAKING VALVE WAS PLACED. PATIENT CAME IN FOR REASSESSMENT THE FOLLOWING DAY AFTER NOTIFYING THIS FACILITY. PATIENT VALVE WAS LEAKING. IT WAS REMOVED AND NOTED TO BE WARPED WHICH WAS CAUSING LEAKING. PATIENT REPORTED THE LEAKING STARTED ON THE FIRST DAY OF VALVE PLACEMENT BUT DID NOT NOTIFY THE FACILITY OR STAFF UNTIL APPROXIMATELY 6 WEEKS LATER. THE VALVE IS BEING SENT BACK TO THE MANUFACTURER FOR REASSESSMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478903 INHEALTH SPEAKING VALVE PROSTHESIS, LARYNGEAL EWL INTERNATIONAL HEALTH TECHNOLOGIES * *

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR