BEUDAMED
    FDA Adverse Event Other Summary report: N

    BLOM - SINGER

    MDR report key: 2894860 · Received November 26, 2008

    Report

    Report Number
    2025182-2008-00004
    Event Type
    Other
    Date Received
    November 26, 2008
    Date of Event
    October 22, 2008
    Report Date
    November 26, 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 ON (B)(6) 2008. TERMINAL ILL PT'S WIFE PUSHED VOICE PROSTHESIS DOWN HUSBAND'S ESOPHAGUS. SLP AND NURSE ADVISED ER CARE TO CHECK BRONCHUS AND GI TRACT FOR DEVICE. IT WAS NOT LOCATED. PT IS STABLE AND WILL BE MONITORED TO ADDRESS OF CHANGES TO GASTROINTESTINAL STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLOM - SINGER VOICE PROSTHESIS EWL HELIX MEDICAL, LLC IN2006CEF NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention