BEUDAMED
    FDA Adverse Event Summary report: N

    BLOM SINGER ADVANTAGE

    MDR report key: 671823 · Received February 1, 2006

    Report

    Report Number
    2025182-2006-00003
    Date Received
    February 1, 2006
    Date of Event
    December 30, 2005
    Report Date
    January 31, 2006
    Manufacturer
    INHEALTH TECHNOLOGIES, A DIVISION OF HELIX MEDICAL, INC.
    Product Code
    EWL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    PT HAD A "STRONG COUGHING EVENT" AND COUGHED THE DEVICE OUT. PT ATTEMPTED TO PUT THE CLINICIAN MAINTAINED DEVICE BACK IN HIMSELF, USING TWEEZERS AND Q-TIPS, AND ENDED UP ASPIRATING THE DEVICE. PT DIDN'T EXPERIENCE RESPIRATORY DISTRESS SO PT WAITED UNTIL THE NEXT DAY WHEN HE HAD AN APPOINTMENT WITH HIS DOCTOR. THE DEVICE WAS REMOVED IN THE OR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLOM SINGER ADVANTAGE INDWELLING VOICE PROSTHESIS EWL INHEALTH TECHNOLOGIES, A DIVISION OF HELIX MEDICAL, INC. * 759649

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention