BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURITY

    MDR report key: 8495895 · Received April 9, 2019

    Report

    Report Number
    8040459-2019-00043
    Event Type
    Injury
    Date Received
    April 9, 2019
    Report Date
    May 8, 2019
    Manufacturer
    KENDALL GAMMATRON, THAILAND
    Product Code
    BTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT HAS BEEN REASSESSED. THE EVENT IS NO LONGER CONSIDERED AS MALFUNCTION AND IS NOW CLASSIFIED AS A SERIOUS INJURY. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    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 A NORMAL USE, THE DEVICE'S CUFF HAD INFLATION/DEFLATION ISSUE. THE BALLOON LEAKED. THE DECANNULATION/REINTUBATION REQUIRED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, DURING A NORMAL USE, THE DEVICE'S CUFF HAD INFLATION/DEFLATION ISSUE. THE BALLOON LEAKED. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288374 CURITY TUBE, TRACHEAL (W/WO CONNECTOR) BTR KENDALL GAMMATRON, THAILAND 9570E 1812548FED

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention