BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREMIER FIBRELIGHT MCCOY SIZE 3

    MDR report key: 2891102 · Received December 20, 2012

    Report

    Report Number
    9610531-2012-00002
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Date of Event
    October 21, 2012
    Report Date
    December 19, 2012
    Manufacturer
    PENLON LTD
    Product Code
    CCW
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT UNDER INVESTIGATION.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT A METAL PIECE FROM THE BLADE BROKE OFF DURING THE INTUBATION PROCEDURE AND LODGED IN THE AIRWAY OF THE PATIENT. MEDICAL INTERVENTION WAS REQUIRED TO REMOVE IT FROM THE PATIENT'S AIRWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PREMIER FIBRELIGHT MCCOY SIZE 3 RIGID LARYNGOSCOPE CCW PENLON LTD NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other