BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMBU AURA I SINGLE-USE LARYNGEAL MASK #5

    MDR report key: 1985468 · Received February 7, 2011

    Report

    Report Number
    MW5019345
    Event Type
    Injury
    Date Received
    February 7, 2011
    Date of Event
    February 3, 2011
    Report Date
    February 7, 2011
    Manufacturer
    AMBU INC
    Product Code
    CAE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AMBU AURAI SINGLE-USE LARYNGEAL MASK #5, LOT 1253729, BECAME PARTIALLY DISRUPTED BETWEEN ITS HANDLE AND THE REMAINDER OF THE DEVICE DURING USE. A LEAK WAS NOTED IN THE ANESTHESIA CIRCUIT. ANESTHESIOLOGIST REAPPROXIMATED AND TAPED THE DISRUPTED PORTION DURING THE CASE. NO HARM TO THE PT WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMBU AURA I SINGLE-USE LARYNGEAL MASK #5 LARYNGEAL MASK AIRWAY CAE AMBU INC #5 1253729

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability