BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTRACH TUBE 6MM EMG FLEX

    MDR report key: 1881591 · Received October 25, 2010

    Report

    Report Number
    1045254-2010-00053
    Event Type
    Injury
    Date Received
    October 25, 2010
    Date of Event
    July 13, 2010
    Report Date
    September 28, 2010
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    BSK
    PMA / PMN Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE MANUFACTURE DATE IS UNKNOWN. IT THE SITE REPORTED THE PATIENT HAS DEVELOPED NEUROLOGIC PROBLEMS AND WAS ADMITTED TO A NEUROLOGIC CENTER. IT IS NOT KNOWN IF THE PATIENT'S OUTCOME IS RELATED IN ANYWAY TO THE USE OF THIS MEDTRONIC PRODUCT. THE REPORTING FACILITY HAD DISPOSED OF THE PRODUCT IN QUESTION, AND DID NOT RECORD THE LOT NUMBER. ANY MISSING OR INCOMPLETE DATA ON FORM 3500A IS RESULT OF INFORMATION NOT BEING PROVIDED OR RELEASED BY THE REPORTER DESPITE ATTEMPTS TO OBTAIN THE REQUIRED INFORMATION. THE PRODUCT IS USED FOR TREATMENT AND NOT FOR DIAGNOSIS

    Description of Event or Problem · 1

    THE FACILITY REPORTED APPROXIMATELY NINETY MINUETS INTO A THYROIDECTOMY THE PATIENT ENCOUNTERED A MAJOR BRONCHOSPASM WITH HYPOXIA WHICH REPORTEDLY LASTED FOR SEVERAL MINUTES. IN ADDITION, THE PATIENT DEVELOPED LUNG EDEMA. THE ANESTHESIOLOGIST STATED PATIENT WAS PROPERLY INTUBATED. THE FACILITY DID NOT REPORT IF THE PATIENT HAD ANY PRE-EXISTING CONDITIONS PRIOR TO THE PROCEDURE. NO ADDITIONAL INFORMATIONAL FOR THIS EVENT IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTRACH TUBE 6MM EMG FLEX BSK MEDTRONIC XOMED INC. 8229960 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00049 Required Intervention