EMA NI

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 2019-04-25 for EMA NI manufactured by Prismatik Dentalcraft, Inc..

Event Text Entries

[143245444] The office advised the reported nightguard was already sent out; however, the nightguard has not been received at the time of this report. Once the nightguard is received and evaluation is completed, a supplemental report will be submitted. This report is for the upper tray of the nightguard. Please reference 3011649314-2019-00132 ((b)(4)) for the lower tray.
Patient Sequence No: 1, Text Type: N, H10


[143245445] This report is for the upper tray of the nightguard: it was reported that a patient experienced an allergic reaction after using the ema nightguard. After using the nightguard for about 3 months, the patient developed sores on the tip/edge of the tongue and the corners of the lips where they made contact with the nightguard. Upon experiencing the reaction, the patient stopped using the nightguard and the patient started to heal right away. The patient did not require any treatment for the reaction. The patient was reported to be doing good. The patient has no relevant pre-existing condition; however, the patient has sulfa, penicillin and thromycin allergies. The doctor did not make any adjustment to the nightguard. The patient only rinsed and cleaned the nightguard with water and sensodyne toothpaste.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3011649314-2019-00131
MDR Report Key8553200
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2019-04-25
Date of Report2019-04-25
Date of Event2019-03-18
Date Mfgr Received2019-03-27
Device Manufacturer Date2018-12-28
Date Added to Maude2019-04-25
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 NameEMA
Generic NameANTI-SNORING DEVICE, EMA
Product CodeLRK
Date Received2019-04-25
Model NumberNI
Catalog NumberNI
Lot NumberNI
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. Other 2019-04-25

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