BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUEDEL STYLE 660 LARYNGOSCOPE BLADE

    MDR report key: 2926208 · Received January 15, 2013

    Report

    Report Number
    1316463-2012-00013
    Event Type
    Injury
    Date Received
    January 15, 2013
    Date of Event
    December 4, 2012
    Report Date
    December 18, 2012
    Manufacturer
    WELCH ALLYN, INC.
    Product Code
    CCW
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LAMP BREAK WAS CONFIRMED BY A VISIT TO THE CUSTOMER. THIS LARYNGOSCOPE ALLEGATION IS STILL UNDER EVAL. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVAL IS COMPLETE.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED ON (B)(6) 2012, A PATIENT CODED, FOR UNKNOWN REASONS, AND FOUR (4) ATTEMPTS WERE MADE TO INTUBATE THE PATIENT. THE FOURTH INTUBATION ATTEMPT WAS SUCCESSFUL. THE INITIAL CHEST X-RAY AFTER INTUBATION WAS STATED TO BE CLEAR. ON (B)(6) 2012, A SUBSEQUENT CHEST X-RAY REVEALED A FOREIGN OBJECT IN THE PT¿S LUNG. A BRONCHOSCOPY WAS PERFORMED TO RETRIEVE A FOREIGN OBJECT WHICH WAS IDENTIFIED AS A LAMP FROM A LARYNGOSCOPE BLADE THAT WAS USED DURING INTUBATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22999 GUEDEL STYLE 660 LARYNGOSCOPE BLADE CCW WELCH ALLYN, INC. 66004

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention