BEUDAMED
    FDA Adverse Event Other Summary report: N

    BLOM-SINGER

    MDR report key: 1416658 · Received April 30, 2009

    Report

    Report Number
    2025182-2009-00001
    Event Type
    Other
    Date Received
    April 30, 2009
    Date of Event
    March 30, 2009
    Report Date
    April 29, 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

    PATIENT COUGHED REAL HARD AND DEVICE WAS ASPIRATED, AS DESCRIBED BY PATIENT'S SISTER. DOCTOR ADVISED BRONCHOSCOPY WHICH WAS PERFORMED. NO DEVICE WAS OBSERVED. PATIENT CONTINUES TO DO WELL WITH NO CONSEQUENCES DUE TO EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLOM-SINGER VOICE PROSTHESIS EWL HELIX MEDICAL, LLC BE2014 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention