BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LARYNGEAL MASK AIRWAY

    MDR report key: 318387 · Received February 27, 2001

    Report

    Report Number
    9681900-2001-00009
    Event Type
    Malfunction
    Date Received
    February 27, 2001
    Report Date
    January 19, 2001
    Manufacturer
    THE LARYNGEAL MASK COMPANY
    Product Code
    CAE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A USER FACILITY REPORTED THAT THE LMA AIRWAY TUBE BROKE INTO 2 PIECES DURING USE IN A PT. THE PHYSICIAN REPORTED THAT THE TUBE AT THE POINT OF THE BREAK WAS ROUGH AND THE TIP HAD BEEN TRAPPED MOMENTARILY BEHIND THE UVULA. THE EAR, NOSE, THROAT PHYSICIAN EXAMINED THE PT AND NOTED A SMALL LACERATION ON THE UVULA THAT DID NOT REQUIRE TREATMENT. NO MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED, NOR WAS THERE ANY PERMANENT PROBLEM TO THE PT AS A RESULT OF THE EVENT. THE USER FACILITY WILL NOT BE RETURNING THE DEVICE FOR INVESTIGATION, SINCE IT WAS MORE THAN 6 YEARS OLD (IT WAS PURCHASED 11/8/94) AND MOST LIKELY BROKE DUE TO OVERUSE. LABELING STATES THAT THE LMA IS WARRANTED NOT TO HAVE DEFECTS IN MATERIAL OR WORKMANSHIP FOR A YEAR OR 40 USES, WHICHEVER COMES FIRST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7998 LARYNGEAL MASK AIRWAY OROPHARYNGEAL AIRWAY CAE THE LARYNGEAL MASK COMPANY LMA-CLASSIC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN