BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURITY

    MDR report key: 7536973 · Received May 23, 2018

    Report

    Report Number
    8040459-2018-00050
    Event Type
    Injury
    Date Received
    May 23, 2018
    Report Date
    May 23, 2018
    Manufacturer
    KENDALL GAMMATRON, THAILAND
    Product Code
    BTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH 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, DURING THE PROCEDURE, THE FIRST BALLOON, DEFLATED WHICH CAUSED PATIENT TO BE EXTUBATED. ON THE OTHER HAND, THE SECOND BALLOON CONSTANTLY INFLATE. THE CUSTOMER REPORTED THAT THE PATIENT STATUS WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380913 CURITY TUBE, TRACHEAL (W/WO CONNECTOR) BTR KENDALL GAMMATRON, THAILAND 9475E

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention