BEUDAMED
    FDA Adverse Event Death Summary report: N

    HOOD TRACHEAL STENT WITH POST

    MDR report key: 349432 · Received August 30, 2001

    Report

    Report Number
    MW1022754
    Event Type
    Death
    Date Received
    August 30, 2001
    Date of Event
    August 3, 2001
    Report Date
    August 30, 2001
    Manufacturer
    HOOD LABS
    Product Code
    JCT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PATIENT WITH SUBGLOTTIC AND TRACHEAL STENOSIS FOLLOWING A TRAFFIC ACCIDENT 1 1/2 YEARS AGO. TRACHEAL STENT PLACED EMERGENTLY REPLACING T-TUBE IN TRACH. RETURNED HOME AND WAS IN MILD TO MODERATE RESPIRATORY DISTRESS FOR A FEW DAYS. SPENT 1 OR 2 NIGHTS AT A NEIGHBOR'S HOUSE WHO HAD AIR CONDITIONING, THEN VISITED LOCAL EMERGENCY DEPT. IMPROVED AFTER BREATHING TREATMENT. THEN SAT UP IN BED, COULD NOT BREATHE, COLLAPSED. MD AT BEDSIDE WITHIN 30 SECONDS. COULD NOT "BAG" VENTILATE PT. PT STARTING SEIZING AND WAS GIVEN SUXAMETHONIUM AND WAS INTUBATED. STILL WAS UNABLE TO "BAG" VENTILATE PT. ENDOTRACHEAL TUBE ADVANCED UNTIL HUB IN MOUTH, WITH NO IMPROVEMENT. PATIENT EXPIRED. AUTOPSY DECLINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39864 HOOD TRACHEAL STENT WITH POST TRACHEAL STENT JCT HOOD LABS TSP-1470 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Death