BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AURA 40 REUSABLE

    MDR report key: 12142047 · Received July 9, 2021

    Report

    Report Number
    1220828-2018-00007
    Event Type
    Injury
    Date Received
    July 9, 2021
    Date of Event
    June 13, 2018
    Report Date
    July 10, 2018
    Manufacturer
    BESMED HEALTH BUSINESS CORPORATION
    Product Code
    CAE
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    WA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    SUPPLIER IMPLEMENTED 100% INSPECTION IN REFERENCE TO TRIMMING. MANUFACTURE INSTRUCTION FOR USE FOR FUNCTIONAL TESTING PRIOR TO DEVICE USE WAS NOT FOLLOWED BY THE USER. T

    Description of Event or Problem · 1

    THE NEW LARYNGEAL MASK WAS INSERTED INTO A PATIENT, THERE WAS NO HOLE IN THE TUBING FOR THE OXYGEN AND SEVOFLURANE TO ENTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1038944 AURA 40 REUSABLE LARYNGEAL MASK CAE BESMED HEALTH BUSINESS CORPORATION 703F154

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention