BEUDAMED
    FDA Adverse Event Summary report: N

    *

    MDR report key: 671818 · Received February 1, 2006

    Report

    Report Number
    2025182-2006-00001
    Date Received
    February 1, 2006
    Report Date
    January 31, 2006
    Manufacturer
    INHEALTH TECHNOLOGIES, A DIVISION OF HELIX MEDICAL, INC.
    Product Code
    EWL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    BASED ON INFO PROVIDED BY THE SLP, THIS EVENT HAPPENED APPROX 18 MONTHS AGO. PT STATED "PROSTHESIS FELL DOWN HOLE." PT PUSHED DEVICE BACK USING A FOREIGN OBJECT AGAINST THE ADVICE OF THE SLP. PT STATED "I HAD TO BE OPERATED ON TO GET IT OUT, BECAUSE IT WAS IN MY ESOPHAGUS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * VOICE PROSTHESIS EWL INHEALTH TECHNOLOGIES, A DIVISION OF HELIX MEDICAL, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention