BEUDAMED
    FDA Adverse Event Other Summary report: N

    BLOM - SINGER

    MDR report key: 1038741 · Received May 6, 2008

    Report

    Report Number
    2025182-2008-00001
    Event Type
    Other
    Date Received
    May 6, 2008
    Date of Event
    April 8, 2008
    Report Date
    May 7, 2008
    Manufacturer
    HELIX MEDICAL, LLC
    Product Code
    EWL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER CONTACTED OUR CO IN 2008, WITH FOLLOWING INFO. ON THE PREVIOUS MONTH, HE EXPERIENCED HEAVY COUGHING AND DEVICE WENT INTO HIS AIRWAY. HE WENT TO SEEK MEDICAL ATTENTION, DEVICE LOCATED AT TOP OF LUNG. PROSTHESIS WAS REMOVED, AND DISCARDED BY HOSP STAFF. HE REPORTED THAT HE IS FEELING WELL. PT DID STATE THAT HE HAS A SENSITIVITY TO POLLEN, WHICH MAKES HIM COUGH.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention