BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURITY

    MDR report key: 11138785 · Received January 8, 2021

    Report

    Report Number
    8040459-2021-00001
    Event Type
    Malfunction
    Date Received
    January 8, 2021
    Date of Event
    September 30, 2018
    Report Date
    January 8, 2021
    Manufacturer
    KENDALL GAMMATRON, THAILAND
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    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, THE DEVICE'S CUFF HAD A LEAK. THERE WAS NO REPORTED PATIENT INVOLVEMENT OR OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39716 CURITY TUBE, TRACHEAL (W/WO CONNECTOR) BTR KENDALL GAMMATRON, THAILAND 9570E 1608630FED

    Patients

    Seq Age Sex Outcome Treatment
    1