BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLOM-SINGER ADVANTAGE

    MDR report key: 5579976 · Received April 14, 2016

    Report

    Report Number
    2025182-2016-00002
    Event Type
    Injury
    Date Received
    April 14, 2016
    Date of Event
    January 15, 2016
    Report Date
    April 14, 2016
    Manufacturer
    FREUDENBERG MEDICAL, LLC
    Product Code
    EWL
    PMA / PMN Number
    K991587
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT VOICE PROSTHESIS LEAKED. THEY STATED THEY WERE IN THE HOSPITAL FOR ASPIRATION PNEUMONIA POSSIBLY DUE TO THE LEAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232267 BLOM-SINGER ADVANTAGE VOICE PROSTHESIS EWL FREUDENBERG MEDICAL, LLC AD2010-NS

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization