BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLOM-SINGER VOICE PROSTHESIS

    MDR report key: 4273005 · Received November 17, 2014

    Report

    Report Number
    2025182-2014-00003
    Event Type
    Injury
    Date Received
    November 17, 2014
    Date of Event
    November 11, 2014
    Report Date
    November 11, 2014
    Manufacturer
    HELIX MEDICAL, LLC
    Product Code
    EWL
    PMA / PMN Number
    K932120
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE PT REPORTED THAT WHILE THEY WERE INSERTING THEIR VOICE PROSTHESIS THEY INHALED AND SWALLOWED THE PROSTHESIS. AFTER A CONSULT WITH X-RAYS PERFORMED, THE PT WAS THEN SCHEDULED FOR A BRONCHOSCOPY TO VERIFY IF THE PROSTHESIS HAS DROPPED INTO THE LUNGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    741061 BLOM-SINGER VOICE PROSTHESIS VOICE PROSTHESIS EWL HELIX MEDICAL, LLC IN2014-NS 1006372

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention