BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURITY

    MDR report key: 7910869 · Received September 26, 2018

    Report

    Report Number
    8040459-2018-00072
    Event Type
    Injury
    Date Received
    September 26, 2018
    Date of Event
    September 4, 2018
    Report Date
    September 26, 2018
    Manufacturer
    KENDALL GAMMATRON, THAILAND
    Product Code
    BTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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, INTRA-OPERATIVELY, THE DEVICE¿S CUFF WAS DAMAGED. IT WAS REPORTED THAT THE PHYSICIAN INTUBATED THE PATIENT THROUGH NASAL TRACHEA; A THREE CONSECUTIVE NASAL INTUBATION WAS PERFORMED. IT WAS STATED THAT THE CUFF WAS LEAKING AND REQUIRED RE PLACEMENT. THE CUSTOMER REPORTED THAT THE PATIENT HAD MUCOSAL INJURY, BLEEDING DUE TO THREE CONSECUTIVE NASAL INTUBATION, AND PHYSICIAN REQUIRED TO PERFORM ORAL INTUBATION AS AN ALTERNATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    749992 CURITY TUBE, TRACHEAL (W/WO CONNECTOR) BTR KENDALL GAMMATRON, THAILAND 9475E 1627937FED

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention