BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURITY

    MDR report key: 8978187 · Received September 9, 2019

    Report

    Report Number
    8040459-2019-00098
    Event Type
    Injury
    Date Received
    September 9, 2019
    Date of Event
    August 2, 2019
    Report Date
    September 9, 2019
    Manufacturer
    KENDALL GAMMATRON, THAILAND
    Product Code
    BTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS NOT SOLD IN US AND IS 510(K) EXEMPT. THIS REPORT IS ASSOCIATED TO A SIMILAR PRODUCT SOLD IN THE US WITH 510(K) NUMBER K892432. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, AFTER THE TRACHEAL INTUBATION WAS INSERTED, THE AIR BAG WAS FOUND TO BE LEAKING WHEN GAS WAS INJECTED. THE PRODUCT WAS REPLACED IMMEDIATELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    767838 CURITY TUBE, TRACHEAL (W/WO CONNECTOR) BTR KENDALL GAMMATRON, THAILAND 9475E 1835452FED

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention