BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURITY

    MDR report key: 9881908 · Received March 26, 2020

    Report

    Report Number
    8040459-2020-00019
    Event Type
    Injury
    Date Received
    March 26, 2020
    Report Date
    March 26, 2020
    Manufacturer
    KENDALL GAMMATRON, THAILAND
    Product Code
    BTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER HEALTH CARE 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.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, THE DEVICE WAS TOO SOFT AND TRIED THE INTUBATION FOR THREE TIMES TO THE NEONATAL PREMATURE PATIENT, BUT CONSEQUENTLY THERE WAS AN INJURY IN MUCOUS MEMBRANE AND THEY HAD TO REANIMATE NEONATAL PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    345762 CURITY TUBE, TRACHEAL (W/WO CONNECTOR) BTR KENDALL GAMMATRON, THAILAND 9335E

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention