BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BRITE PRO SOLO

    MDR report key: 4080796 · Received September 5, 2014

    Report

    Report Number
    MW5038111
    Event Type
    Injury
    Date Received
    September 5, 2014
    Date of Event
    June 2, 2014
    Report Date
    September 5, 2014
    Manufacturer
    FLEXICARE
    Product Code
    CCW
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    PATIENT INTUBATED WITH BRITS PRO SOLO LARYNGOSCOPE AND SUSTAINED AIRWAY INJURY NECESSITATING SUTURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    543271 BRITE PRO SOLO LARYNGOSCOPE CCW FLEXICARE 040-333U

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention