COMFORT HARD-SOFT BITE SPLINT 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 2019-05-02 for COMFORT HARD-SOFT BITE SPLINT NI manufactured by Prismatik Dentalcraft, Inc..

Event Text Entries

[143936492] The reported device was sent and pending to be received. Once the device is received and evaluation is completed, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10


[143936493] It was reported that a patient experienced an allergic reaction after using a comfort hard-soft bite splint. On the 3rd day of using the mouthguard, the patient developed blisters, swelling, irritation and redness all around the mouth. Upon experiencing the reaction, the patient stopped using the mouthguard. The reaction went away after 2 days. The patient did not require any treatment for the reaction. The patient was reported to be doing fine. The patient is very sensitive and has many allergies including grass and certain foods. The patient has no relevant medical pre-existing condition. The doctor made adjustment to the occlusal side on the mouthguard's upper right. The patient was recommended to clean the mouthguard using soap and brushes.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3011649314-2019-00139
MDR Report Key8575888
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2019-05-02
Date of Report2019-07-31
Date of Event2019-03-22
Date Mfgr Received2019-07-31
Device Manufacturer Date2019-03-12
Date Added to Maude2019-05-02
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 NameCOMFORT HARD-SOFT BITE SPLINT
Generic NameTHERMOFORMED MOUTHGUARD, COMFORT SPLINT
Product CodeMQC
Date Received2019-05-02
Model NumberNI
Catalog NumberNI
Lot NumberNI
OperatorLAY USER/PATIENT
Device AvailabilityN
Device AgeDA
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 2019-05-02

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