BEUDAMED
    FDA Adverse Event Other Summary report: N

    BLOM-SINGER

    MDR report key: 1546515 · Received August 4, 2009

    Report

    Report Number
    2025182-2009-00002
    Event Type
    Other
    Date Received
    August 4, 2009
    Date of Event
    July 4, 2009
    Report Date
    August 3, 2009
    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

    OUR COMPANY RECEIVED REPORT OF THIS EVENT ON (B)(6) 2009. WHILE DOING YARD WORK, HIS VP SAFETY STRAP CAME OUT. ONCE INSIDE, HE FORGOT TO REPLACE THE TAPE THAT HE HAD HOLDING IT IN PLACE. WHILE EATING HE STARTING COUGHING AND THE PROSTHESIS WAS DISLODGED INTO HIS TRACHEA. HE RECEIVED A BRONCHOSCOPY SAME DAY. THE PROSTHESIS WAS SUCCESSFULLY REMOVED FROM HIS LUNG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLOM-SINGER VOICE PROSTHESIS EWL HELIX MEDICAL, LLC BE6012 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention