BEUDAMED
    FDA Adverse Event Death Summary report: N

    FROVA INTUBATING INTRODUCER

    MDR report key: 7547985 · Received May 29, 2018

    Report

    Report Number
    3002808486-2018-00611
    Event Type
    Death
    Date Received
    May 29, 2018
    Report Date
    June 25, 2018
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    LRC
    PMA / PMN Number
    E597079
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2016032. WILLIAM COOK EUROPE APS (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI) (IMPORTER). MANUFACTURER REF# (B)(4). G1) NAME AND ADDRESS FOR IMPORTER SITE: COOK MEDICAL INCORPORATED (CMI) 400 DANIELS WAY BLOOMINGTON, IN 47404 REGISTRATION NO.: 3005580113. SUMMARY OF INVESTIGATIONAL FINDINGS: NO PRODUCT WAS RETURNED, NO IMAGING WAS PROVIDED, AND ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE UNSUCCESSFUL. IT WAS REPORTED THAT THE PATIENT DIED, BUT THE ACTUAL CAUSE OF DEATH IS UNCLEAR, EG PNEUMOTHORAX WITH TENSION, GAS EMBOLI, ETC. ALSO, IT IS UNKNOWN, WHY OXYGEN WAS USED AT HIGH PRESSURE DOWN THE FROVA IN FIRST PLACE. CONSEQUENTLY, BASED ON VERY LIMITED INFORMATION PROVIDED THE EXACT REASON FOR THE INCIDENT CANNOT BE DETERMINED, BUT IT IS NOTED THAT THE PHYSICIAN CONSIDERED IT A MIS-USE OF THE DEVICE. NO EVIDENCE TO SUGGEST THAT THIS DEVICE WAS NOT MANUFACTURED ACCORDING TO SPECIFICATIONS AND NOTHING INDICATES THAT IT DID NOT PERFORM AS INTENDED. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2016032. WILLIAM COOK EUROPE APS (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI) (IMPORTER). MANUFACTURER REF# (B)(4). G1) NAME AND ADDRESS FOR IMPORTER SITE: COOK MEDICAL INCORPORATED (CMI) 400 DANIELS WAY BLOOMINGTON, IN 47404 REGISTRATION NO.: 3005580113. (B)(4). INVESTIGATION IS STILL IN PROGRESS.

    Description of Event or Problem · 0

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: DURING A CONFERENCE, AN ANESTHETIST REPORTED TO A COOK MEDICAL REPRESENTATIVE THAT 8 YEARS AGO AT THE HEALTHCARE FACILITY, A PATIENT WAS OXYGENATED DOWN A FROVA BOUGIE. HOWEVER, THE BOUGIE WAS INSERTED TOO FAR DOWN, THE OXYGEN THAT WAS ADMINISTERED WAS HIGH PRESSURE AND THE PATIENT DIED AS A RESULT. PATIENT OUTCOME: PATIENT DIED.

    Description of Event or Problem · 0

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: DURING A CONFERENCE, AN ANESTHETIST REPORTED TO A COOK MEDICAL REPRESENTATIVE THAT 8 YEARS AGO AT THE HEALTHCARE FACILITY, A PATIENT WAS OXYGENATED DOWN A FROVA BOUGIE. HOWEVER, THE BOUGIE WAS INSERTED TOO FAR DOWN, THE OXYGEN THAT WAS ADMINISTERED WAS HIGH PRESSURE AND THE PATIENT DIED AS A RESULT. PATIENT OUTCOME: PATIENT DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392622 FROVA INTUBATING INTRODUCER LRC INSTRUMENT, ENT MANUAL SURGICAL LRC WILLIAM COOK EUROPE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Death