BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLOM-SINGER

    MDR report key: 676069 · Received February 10, 2006

    Report

    Report Number
    2025182-2006-00004
    Event Type
    Injury
    Date Received
    February 10, 2006
    Date of Event
    January 10, 2006
    Report Date
    February 10, 2006
    Manufacturer
    INHEALTH TECHNOLOGIES, A DIVISION OF HELIX MEDICAL, INC.
    Product Code
    MCK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT CALLED TO COMPLAINT THAT "GLUE WAS NOT STICKING." TOWARDS END OF CONVERSATION PT STATED THAT A VOICE PROSTHESIS "FELL DOWN HIS LUNGS LAST WEEK." PT STATED HE "HAD TO GO TO THE HOSP, BE PUT TO SLEEP AND A MECHANICAL DEVICE BE PUT DOWN HIS STOMACH TO RETRIEVE THE PROSTHESIS." PT STATED "THE PROSTHESIS IS FINE AND IT IS THE GLUE'S FAULT THIS HAPPENED." PT IS STILL USING THE PROSTHESIS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention