NTI REFILL KIT-NIGHTLINE 7700 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2000-03-14 for NTI REFILL KIT-NIGHTLINE 7700 * manufactured by Heraeus Kulzer, Inc..

Event Text Entries

[191416] 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.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1925223-2000-00003
MDR Report Key270003
Report Source05
Date Received2000-03-14
Date of Report2000-03-13
Date Mfgr Received2000-02-16
Date Added to Maude2000-03-22
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationDENTIST
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location0
Manufacturer Street4315 S. LAFAYETTE BLVD
Manufacturer CitySOUTH BEND IN 46614
Manufacturer CountryUS
Manufacturer Postal46614
Manufacturer Phone2192910661
Manufacturer G1*
Manufacturer Street*
Manufacturer City*
Manufacturer Country*
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameNTI REFILL KIT-NIGHTLINE
Generic Name*
Product CodeLQZ
Date Received2000-03-14
Model Number7700
Catalog Number*
Lot Number*
ID Number*
OperatorHEALTH PROFESSIONAL
Device Eval'ed by MfgrR
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key261398
ManufacturerHERAEUS KULZER, INC.
Manufacturer Address4315 S. LAFAYETTE BLVD. SOUTH BEND IN 46614 US
Baseline Brand NameNTI REFILL KIT - NIGHTIME
Baseline Generic Name*
Baseline Model No7700
Baseline Catalog No7700
Baseline ID*


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2000-03-14

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