COMFORT HARD-SOFT BITE SPLINT?

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 2020-02-24 for COMFORT HARD-SOFT BITE SPLINT? manufactured by Prismatik Dentalcraft, Inc..

MAUDE Entry Details

Report Number3011649314-2020-00474
MDR Report Key9744713
Report SourceHEALTH PROFESSIONAL
Date Received2020-02-24
Date of Report2020-02-24
Date Mfgr Received2020-01-30
Device Manufacturer Date2019-08-01
Date Added to Maude2020-02-24
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
Manufacturer CountryUS
Manufacturer Phone4402632
Manufacturer G1PRISMATIK DENTALCRAFT, INC.
Manufacturer Street2212 DUPONT DR SUITE P
Manufacturer CityIRVINE, CA
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCOMFORT HARD-SOFT BITE SPLINT?
Generic NameTHERMOFORM MOUTHGUARD
Product CodeMQC
Date Received2020-02-24
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 US


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-02-24

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