BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLOM-SINGER

    MDR report key: 6817200 · Received August 24, 2017

    Report

    Report Number
    2025182-2016-00007
    Event Type
    Injury
    Date Received
    August 24, 2017
    Date of Event
    September 27, 2016
    Report Date
    November 18, 2016
    Manufacturer
    FREUDENBERG MEDICAL, LLC
    Product Code
    EWL
    PMA / PMN Number
    K800563
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT'S SPOUSE CALLED IN ON 10/27/2016 TO REPORT THE PATIENT'S VOICE PROSTHESIS STARTED LEAKING. THE DEVICE WAS PLACED ON (B)(6) 2016 AND REMOVED DUE TO THE EVENT ON (B)(6) 2016. THE PATIENT WAS SEEN BY THEIR SPEECH LANGUAGE PATHOLOGIST (SLP) WHO STATED THE PATIENT HAD AN INFECTION IN THE TRACHEA. THE PATIENT WAS SUBSEQUENTLY ADMITTED TO THE HOSPITAL FOR PNEUMONIA. FOLLOW UP WITH THE SLP FOUND THAT THE DEVICE WAS "COLONIZED WITH FUNGAL GROWTH" WHICH REPORTEDLY LEAD TO THE LEAKAGE AND THE SUBSEQUENT INFECTION AND PNEUMONIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    597356 BLOM-SINGER VOICE PROSTHESIS EWL FREUDENBERG MEDICAL, LLC 0000040294

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization