BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDOTRACHEAL TUBE

    MDR report key: 3937539 · Received June 19, 2014

    Report

    Report Number
    9611710-2014-00144
    Event Type
    Death
    Date Received
    June 19, 2014
    Date of Event
    November 1, 2013
    Report Date
    June 18, 2013
    Manufacturer
    UNOMEDICAL SDN BHD
    Product Code
    BTR
    PMA / PMN Number
    K951696
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED A SERIOUS INJURY. IT WAS NOTED THAT THE PATIENT HAD COLITIS REQUIRING SURGERY. IT WAS FURTHER REPORTED THAT THE PATIENT WAS RE-INTUBATED AND ADMITTED TO THE INTENSIVE CARE UNIT. NO ADDITIONAL INFORMATION (PRODUCT CODE, LOT NUMBER OR SAMPLE INFORMATION) WAS PROVIDED. NO PATIENT INFORMATION AVAILABLE AND LIMITED INFORMATION PROVIDED ABOUT THE DEATH. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. REPORTED TO THE FDA ON (B)(4) 2014.

    Description of Event or Problem · 1

    THE FOLLOWING COMPLAINT WAS RECEIVED THROUGH OUR LEGAL DEPARTMENT FOR ALLEGED DEATH. IT WAS REPORTED "A PATIENT UNDERWENT A SURGICAL PROCEDURE AND THE ENDOTRACHEAL TUBE LEAKED DEPRIVING HIM OF OXYGEN THUS RESULTING IN CARDIAC ARREST AND DEATH."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359359 ENDOTRACHEAL TUBE TUBE, TRACHEAL (W/WO CONNECTOR) BTR UNOMEDICAL SDN BHD UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death