XTRA SILENT NITE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-01-10 for XTRA SILENT NITE manufactured by Prismatik Dentalcraft, Inc..

Event Text Entries

[180571963] The device has not yet been returned. An investigation will be conducted once the sample has been returned and a supplemental report will be submitted. Weight: asked, but unknown. Date of event: asked, but unknown. Model number: not applicable. Catalog number: not applicable. Lot number: not applicable. Expiration date: not applicable. Udi number: not available.
Patient Sequence No: 1, Text Type: N, H10


[180571964] It was reported that a patient experienced an allergic reaction after using an xtra silent nite slide link appliance. According to the information provided by the doctor, the patient experienced swelling on the lips overnight on unknown date. It is unknown whether or not the patient has any known allergies.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3011649314-2019-00807
MDR Report Key9575563
Report SourceHEALTH PROFESSIONAL
Date Received2020-01-10
Date of Report2020-01-10
Date Mfgr Received2019-12-13
Device Manufacturer Date2019-12-05
Date Added to Maude2020-01-10
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. HERBERT SCHOENHOEFER
Manufacturer Street2212 DUPONT DRIVE SUITE P
Manufacturer CityIRVINE CA 92612
Manufacturer CountryUS
Manufacturer Postal92612
Manufacturer Phone9494402632
Manufacturer G1PRISMATIK DENTALCRAFT, INC.
Manufacturer Street2212 DUPONT DR 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 Received2020-01-10
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerPRISMATIK DENTALCRAFT, INC.
Manufacturer Address2212 DUPONT DRIVE SUITE P IRVINE CA 92612 US 92612


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-01-10

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