BEUDAMED
    FDA Adverse Event Other Summary report: N

    NTI REFILL KIT-NIGHTLINE

    MDR report key: 270003 · Received March 14, 2000

    Report

    Report Number
    1925223-2000-00003
    Event Type
    Other
    Date Received
    March 14, 2000
    Report Date
    March 13, 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

    02/16/2000: RECEIVED A FAX FROM DR STATING: "I HAVE BEEN USING NTI APPLIANCE AS PER MFR'S GUIDELINES AND MFR'S INSTRUCTIONS. A PT HAS RECENTLY REPORTED TO THE DOCTOR THAT PT HAS SWALLOWED APPLIANCE. DOCTOR DOESN'T KNOW HOW TO DIRECT THE PT FOR PROPER TREATMENT. BECAUSE MFR DID NOT MAKE THIS APPLIANCE RADIO-OPAQUE, DOCTOR CAN'T TELL WHETHER PT ASPIRATED THE NTI AND IT IS LODGED IN PT'S LUNGS, WHETHER NTI IS STUCK SOMEWHERE IN PT'S GASTROINTESTINAL TRACT, OR WHAT? DOCTOR DID NOTHING INAPPROPRIATE, BUT BECAUSE OF MFR NOT MAKING THE APPLIANCE RADIO-OPAQUE, DOCTOR DOES NOT KNOW HOW TO REFER PT'S MEDICAL PROBLEM. PT AND DR ARE ANXIOUSLY AWAITING RECOMMENDATIONS AS TO HOW TO PROCEED." 02/16/2000 AT 2:00 PM: CALLED OFFICE AND SPOKE ?. THE OFFICE HAD NO IDEA WHAT REP WAS TALKING ABOUT. THE OFFICE TRIED TO GET THE DR, BUT DOCTOR WAS NOT ANSWERING THE PAGE. THE OFFICE TOOK REPS NAME AND NUMBER AND WOULD HAVE THE DOCTOR CALL REP BACK AT DOCTOR'S CONVENIENCE. 2:05 PM: DOCTOR RETURNED REP'S CALL. DR IS VERY UPSET ABOUT THE PT SWALLOWING THE NTI. PERSON IS A FEMALE PT APPROX 40-50 YEARS OLD. (DOCTOR DID NOT HAVE THE CHART IN FRONT OF HIM.) DOCTOR WAS NOT SURE HOW LONG THE PT HAS BEEN WEARING THE NTI-MAYBE A COUPLE MONTHS. (DOCTOR'S OFFICE HAVE BEEN USING IT FOR THE PAST 6 MONTHS.) DOCTOR SAID THE FIT OF THE APPLIANCE WAS GOOD-DOCTOR'S OFFICE SEE THE PT ONCE A WEEK FOR A CHECK. THE DOCTOR SAID THE PT SWALLOWED THE APPLIANCE ABOUT 2 NIGHTS AGO. THE DOCTOR DID NOT RECOMMEND THE PT GO INTO THE EMERGENCY ROOM. PT IS NOT IN ANY PAIN. DOCTOR IS VERY CONCERNED THAT MFR DID NOT MAKE THE DEVICE RADIO-OPAQUE SO IT WILL NOT SHOW UP ON X-RAYS. PT TOLD DOCTOR THAT DEVICE DID NOT PASS IN PT'S STOOL. PT AND DOCTOR ARE BOTH CONCERNED THAT IT IS STILL IN PT'S BODY SOMEWHERE. REP TOLD THE DOCTOR MFR HAD TWO OTHER REPORTED INCIDENCES OF A PT SWALLOWING A NTI APPLIANCE. BOTH WENT TO SEE A MEDICAL DR AND BOTH PASSED THE APPLIANCE. REP ALSO TOLD DOCTOR THAT REP KNEW ONE OF THE PTS HAD A SCOPE DONE TO FIND THE DEVICE. DOCTOR ASKED THAT MFR SEND HIM A LETTER REGARDING CO'S CONVERSATION SO DOCTOR HAS A RECORD OF CONVERSATION. 2:43 PM: LEFT PAGE MESSAGE REGARDING FOLLOW-UP FOR PT. TOLD DOCTOR THAT REP SPOKE WITH CO'S MGR AND MGR SAID IF THE PT WAS HAVING ANY DISCOMFORT, CO RECOMMENDS PT SEEING THE PHYSICIAN. REP TOLD DOCTOR TO PLEASE CALL IF DR HAS ANY FURTHER QUESTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NTI REFILL KIT-NIGHTLINE * LQZ HERAEUS KULZER, INC. 7700 *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other