BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURITY

    MDR report key: 12751381 · Received November 4, 2021

    Report

    Report Number
    8040459-2021-00086
    Event Type
    Malfunction
    Date Received
    November 4, 2021
    Date of Event
    September 23, 2021
    Report Date
    November 4, 2021
    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, DURING USE, THE CUFF OF THE DEVICE HAD A LEAKAGE. THE TUBE HAS BEEN REPLACED WITHOUT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1653276 CURITY TUBE, TRACHEAL (W/WO CONNECTOR) BTR 9475E 1800930FED

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR