BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOMIMED FIBER OPTICE DISPOSABLE LARYNGOSCOPE BLADE

    MDR report key: 10743337 · Received October 27, 2020

    Report

    Report Number
    3003213883-2020-00001
    Event Type
    Malfunction
    Date Received
    October 27, 2020
    Date of Event
    January 8, 2020
    Report Date
    June 29, 2020
    Manufacturer
    BOMIMED INC
    Product Code
    CCW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    MATTER OCCURRED AND REPORTED IN (B)(6).

    Description of Event or Problem · 1

    AFTER INTUBATION, WHILE ET TUBE WAS BEING SECURED TO PATIENT, RT NOTICED A SMALL PIECE OF PLASTIC (FIBEROPTIC LIGHT CHANNEL) COMING OUT OF PATIENT'S MOUTH. NO HARM TO THE PATIENT AS THE PIECE WAS RETRIEVED WITHOUT COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1209521 BOMIMED FIBER OPTICE DISPOSABLE LARYNGOSCOPE BLADE DISPOSABLE LARYNGOSCOPE BLADE CCW BOMIMED INC MILLER 00 1318

    Patients

    Seq Age Sex Outcome Treatment
    1