BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURITY

    MDR report key: 7588305 · Received June 11, 2018

    Report

    Report Number
    8040459-2018-00053
    Event Type
    Malfunction
    Date Received
    June 11, 2018
    Date of Event
    May 18, 2018
    Report Date
    June 11, 2018
    Manufacturer
    KENDALL GAMMATRON, THAILAND
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    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 SLIP JOINT FELL OUT OF THE TUBE. THE CUSTOMER INDICATED NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430045 CURITY TUBE, TRACHEAL (W/WO CONNECTOR) BTR KENDALL GAMMATRON, THAILAND 9570E 1727243FED

    Patients

    Seq Age Sex Outcome Treatment
    1