BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURITY

    MDR report key: 8755132 · Received July 2, 2019

    Report

    Report Number
    8040459-2019-00072
    Event Type
    Malfunction
    Date Received
    July 2, 2019
    Date of Event
    April 12, 2019
    Report Date
    July 2, 2019
    Manufacturer
    KENDALL GAMMATRON, THAILAND
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    003

    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 JOINT CONNECTION WAS TOO LOOSE AND EASILY FALL OFF. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    546740 CURITY TUBE, TRACHEAL (W/WO CONNECTOR) BTR KENDALL GAMMATRON, THAILAND 9475E 1835336FED

    Patients

    Seq Age Sex Outcome Treatment
    1