BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AED, INC.

    MDR report key: 3918344 · Received May 30, 2014

    Report

    Report Number
    3918344
    Event Type
    Injury
    Date Received
    May 30, 2014
    Date of Event
    May 29, 2014
    Report Date
    May 30, 2014
    Manufacturer
    AES, INC.
    Product Code
    CAE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    EVENT OCCURRED AFTER SURGICAL PROCEDURE WAS COMPLETE, BUT DURING PT EMERGENCE FROM ANESTHESIA. WHILE ATTEMPTING TO EXTUBATE THE #4 LMA (LOT # 402016940), THE LMA CUFF DETACHED FROM THE SHAFT AND THE BALLOON DETACHED FROM THE CUFF. A SMALL FRAGMENT OF THE CUFF BROKE OFF ALSO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319323 AED, INC. SINGLE USE LARYNGEAL MASK CAE AES, INC. 402016940

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention