BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURITY

    MDR report key: 7633963 · Received June 25, 2018

    Report

    Report Number
    8040459-2018-00057
    Event Type
    Injury
    Date Received
    June 25, 2018
    Date of Event
    February 1, 2018
    Report Date
    December 5, 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.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, THE UNIT HAD CUFF INFLATION/DEFLATION ISSUE. PATIENT OUTCOME WAS ASKED BUT UNKNOWN.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, THE UNIT HAD CUFF INFLATION/DEFLATION ISSUE. DURING INTUBATION OF THE PATIENT, THE BALLOON OF THE DEVICE DEFLATED 3 TIMES. THE PATIENT WAS RE-INTUBATED TWICE WITH DIFFERENT UNITS. PATIENT OUTCOME WAS ASKED BUT UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    476738 CURITY TUBE, TRACHEAL (W/WO CONNECTOR) BTR KENDALL GAMMATRON, THAILAND 9475E 1722815FED

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention