BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLOM-SINGER CLASSIC INDWELLING VOICE PROSTHESIS

    MDR report key: 5432374 · Received February 11, 2016

    Report

    Report Number
    2025182-2016-00001
    Event Type
    Injury
    Date Received
    February 11, 2016
    Date of Event
    January 28, 2016
    Report Date
    February 11, 2016
    Manufacturer
    FREUDENBERG MEDICAL, LLC D.B.A. HELIX MEDICAL, LLC
    Product Code
    EWL
    PMA / PMN Number
    K932120
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    WHILE PATIENT WAS IN THE HOSPITAL IN ICU BECAUSE OF PNEUMONIA, THE VOICE PROSTHESIS WAS ASPIRATED. AN ENT DOCTOR PERFORMED A PROCEDURE TO RETRIEVE THE DEVICE FROM THE LUNGS. THE DOCTOR WAS ABLE TO RE-INSERT THE DEVICE IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88205 BLOM-SINGER CLASSIC INDWELLING VOICE PROSTHESIS VOICE PROSTHESIS, PRODUCT CODE: EWL EWL FREUDENBERG MEDICAL, LLC D.B.A. HELIX MEDICAL, LLC IN 2010-LEF 0000014752

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention