BEUDAMED
    FDA Adverse Event Other Summary report: N

    BLOM-SINGER

    MDR report key: 1669200 · Received April 21, 2010

    Report

    Report Number
    2025182-2010-00001
    Event Type
    Other
    Date Received
    April 21, 2010
    Date of Event
    March 11, 2010
    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

    RECEIVED COMPLAINT (B)(6) 2010. PT HAD DEVICE PLACED BY SLP ON (B)(6) 2010. THAT EVENING, DEVICE WAS ASPIRATED. PT UNDERWENT BRONCHOSCOPY TO LOCATE AND REMOVE DEVICE. PT IS DOING WELL AND HAS HAD ANOTHER DEVICE OF SAME MAKE/MODEL PLACED BY HIS HCP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLOM-SINGER VOICE PROSTHESIS EWL HELIX MEDICAL, LLC IN 1604- NS 842489

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention