BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REFILL NTI KIT

    MDR report key: 258432 · Received January 10, 2000

    Report

    Report Number
    1925223-2000-00001
    Event Type
    Injury
    Date Received
    January 10, 2000
    Date of Event
    December 15, 1999
    Report Date
    January 1, 2000
    Manufacturer
    HERAEUS KULZER, INC.
    Product Code
    LQZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    A PT, WOKE AT 2:30 A.M. (12-15-99) TO TAKE AN ASPIRIN. PT. TOOK THE APPLIANCE OUT TO TAKE THE ASPIRIN AND THEN PLACED THE NTI BACK IN MOUTH. FEELING THAT THE ASPIRIN HAD NOT GONE ALL THE WAY DOWN, THE PT. TOOK ANOTHER DRINK OF WATER AND THAT IS WHEN THE PT SWALLOWED THE NTI. PT IMMEDIATELY CALLED THE DR. AND HE TOLD PT. TO GO TO THE E.R. PT. WENT AND HAD THE APPLIANCE SCOPED OUT, SINCE AN X-RAY DOES NOT SHOW THE APPLIANCE. DR. HAS NOT YET SEEN THE PT AND IS NOT SURE OF THE WHOLE STORY. DR. IS EXTREMELY HAPPY WITH THE NTI SYSTEM AND HAS MADE SEVERAL, BUT NOW IS VERY CONCERNED ABOUT MAKING ANY MORE. FOLLOW-UP CALL: PT WAS FITTED WITH THE DEVICE ABOUT 2 MONTHS AGO PER DR. PT HAD IT MADE AND IT WAS TOO TIGHT, THEN CAME BACK IN THE OFFICE AND THE DR. ADJUSTED. THEN IT GOT TOO LOOSE AND THE DR. ADJUSTED A 2ND TIME AND MADE IT TIGHTER. THE LAST THE DR. HEARD WAS THAT THE PT WAS COMPLAINING THAT THE APPLIANCE WAS TOO LOOSE. DR. TOLD THE PT NOT TO WEAR IT UNTIL THE PT CAME BACK IN TO HAVE IT TIGHTENED. PT NEVER CAME BACK IN TO HAVE THE APPLIANCE TIGHTENED. DR SAID THE PT DID IN FACT SWALLOW THE NTI AND IT WAS FOUND BELOW THE WIND PIPE. PT WOKE UP AND COULD NOT FIND THE APPLIANCE AND HAD A PAIN IN CHEST. THAT IS WHEN PT CALLED THE DR. AND DOCTOR RECOMMENDED GOING TO THE E.R.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REFILL NTI KIT * LQZ HERAEUS KULZER, INC. 7600 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization PATIENT WAS ADVISED TO GO TO EMERGENCY ROOM.