BEUDAMED
    FDA Adverse Event Other Summary report: N

    BLOM-SINGER

    MDR report key: 1245467 · Received November 6, 2008

    Report

    Report Number
    2025182-2008-00003
    Event Type
    Other
    Date Received
    November 6, 2008
    Date of Event
    September 23, 2008
    Report Date
    November 6, 2008
    Manufacturer
    HELIX MEDICAL, LLC
    Product Code
    EWL
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    COMPLAINT RECEIVED BY OUR COMPANY ON OCT 7, 2008. PT. WAS WEARING FOAM SUOMA COVER AND IT CAME OFF. SHE BEGAN TO COUGH VIOLENTLY, PUT A HANDKERCHIEF TO HER TEP AND INHALED DEEPLY. HER VOICE PROSTHESIS WAS INHALED INTO RT. BRONCHIAL TUBE DEVICE WAS REMOVED AT HOSPITAL; BACTERIAL CULTURE SHOWED THAT LUNG INFECTION WAS REASON FOR COUGH. ANTIBIOTICS RX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLOM-SINGER VOICE PROSTHESIS EWL HELIX MEDICAL, LLC LP20-014-IR NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention