XTRA SILENT NITE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-02-18 for XTRA SILENT NITE manufactured by Prismatik Dentalcraft, Inc..

Event Text Entries

[136522993] Patient's weight was asked but unknown. Request to have the device return was made; however, the device has not been returned for evaluation yet. Once the device is received and evaluation is completed, a supplemental report will be submitted. This report is for the lower tray of the night guard. Please reference 3011649314-2019-00012 ((b)(4)) for the upper tray.
Patient Sequence No: 1, Text Type: N, H10


[136522994] This report is for the lower tray of the xtra silent nite: it was reported that a patient experienced an allergic reaction after using the xtra silent nite night guard. Originally, the night guard was made for patient under (case # (b)(4)); however, the lower tray was returned for remake for better fit. A new lower tray was sent to patient under (case # (b)(4)). The doctor also made some adjustments to the lower left buccal area on the outside of new lower tray. After using the night guard for about 2 weeks, the patient reported of an allergic reaction. The patient developed rash on the cheeks and the lower lip was swollen. Upon experiencing the reaction, the patient stopped using the night guard and did not resume use. The patient took benadryl to treat the reaction. The symptoms went away after a couple of days. The patient was reported to be doing fine. The patient has no pre-existing condition; however, the patient has skin sensitivity and allergic to some detergents and penicillin. The patient was recommended to clean the night guard with water.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3011649314-2019-00013
MDR Report Key8348864
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2019-02-18
Date of Report2019-05-20
Date of Event2018-12-10
Date Mfgr Received2019-05-20
Device Manufacturer Date2018-11-08
Date Added to Maude2019-02-18
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationDENTIST
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. TOAN HOANG
Manufacturer Street2212 DUPONT DRIVE SUITE P
Manufacturer CityIRVINE CA 92612
Manufacturer CountryUS
Manufacturer Postal92612
Manufacturer Phone9492251235
Manufacturer G1PRISMATIK DENTALCRAFT, INC.
Manufacturer Street2212 DUPONT DRIVE SUITE P
Manufacturer CityIRVINE CA 92612
Manufacturer CountryUS
Manufacturer Postal Code92612
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameXTRA SILENT NITE
Generic NameANTI-SNORING NIGHTGUARD
Product CodeLRK
Date Received2019-02-18
Returned To Mfg2019-03-15
Model NumberNI
Catalog NumberNI
Lot NumberNI
OperatorLAY USER/PATIENT
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerPRISMATIK DENTALCRAFT, INC.
Manufacturer Address2212 DUPONT DRIVE SUITE P IRVINE CA 92612 US 92612


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-02-18

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