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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PRISMATIK DENTALCRAFT, INC. COMFORT3D BITE SPLINT; THERMOFORM MOUTHGUARD

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PRISMATIK DENTALCRAFT, INC. COMFORT3D BITE SPLINT; THERMOFORM MOUTHGUARD Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Hypersensitivity/Allergic reaction (1907)
Event Date 07/26/2022
Event Type  Injury  
Manufacturer Narrative
The device has been returned.Once the investigation is complete a supplemental report will be submitted.The patients weight is not provided as it is not taken at the time of the appointment.The patients race/nationality is noted as indian.
 
Event Description
It was reported that the patient had a reaction to the night guard.The device was issued (b)(6) 2022 and used that evening with the reaction occurring (b)(6) 2022.The patient experienced a sore throat and sore tongue.It is unclear when the patient discontinued the use of the device.The reaction resolved in a day.There was no medical treatment needed.There is no medical history noted and there are no allergies noted as well.Nor has an allergist been sought.With regards to the device: the device was rinsed with sterile water prior to delivery.The provider is not sure how the patient cared for the device.The device has been returned.
 
Manufacturer Narrative
The device was returned, the investigation has been completed and the results are as follows: dhr results.The dhr was reviewed for case #(b)(4) and there was no evidence discovered to indicate that a product defect or non-conformity contributed to the issue.Material lot information was not obtainable.Sufficient due diligence was put forth in an effort to identify the lot number.Stock product reviewed results.No stock product was available for review since the device was fabricated per physician's prescription only.Investigation methods/results.Complaint investigator reviewed the returned device.A lower splint was returned in the original case.The results were summarized: roughness - the flange was smooth; internal/external surfaces were smooth.Crack - no major crack was found.Delamination - layers were intact and did not separate.Discoloration - the device was not discolored.General cleanliness - the returned device appeared to be clean, free of debris or foreign particles.The returned device was visually inspected, and no defect or abnormality was observed.There was no evidence found to indicate that the reported issue was caused by the device itself.Root cause.A root cause for this complaint cannot be explicitly determined.Ifu 12383 rev 3.0 (comfort3d bite splint instruction for use) states "brush and floss your teeth before use.Rinse mouth well with clean water before inserting the device.If patient uses mouthwash, all traces of mouthwash should be removed by thoroughly rinsing out mouth with water.Rinse bite splint well with clean, cool water before and after use.Clean bite splint with clean, cool water only and let air dry." ifu provides warning "do not clean or soak in mouthwash; do not use denture cleanser, hot water, alcohol, hydrogen peroxide; do not place in direct sunlight".It is possible that reactions could be caused by mouthwash, toothpaste, or soaking material.However, the provider is not sure how the patient handled and cared for the device.Rpt 012620 rev.1.0 (comfort3d bite splint verification), confirms that the resin material meets the acceptance criteria for biocompatibility (cytotoxicity, irritation, and sensitization) and mechanical properties (flexural strength, flexural modulus, sorption, solubility, and free monomer extraction).
 
Manufacturer Narrative
Additional data: a6, b2, h6 (type of investigation code).Corrected data: d1, h6 (health effect - impact code).Note: h4 was inadvertently added in the initial report.Insufficient device information was provided to obtain the manufacturing date.Capa 23-006.Manufacturer reference: (b)(4).
 
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Brand Name
COMFORT3D BITE SPLINT
Type of Device
THERMOFORM MOUTHGUARD
Manufacturer (Section D)
PRISMATIK DENTALCRAFT, INC.
2144 michelson drive
irvine CA 92612
Manufacturer (Section G)
PRISMATIK DENTALCRAFT, INC.
2144 michelson drive
irvine CA 92612
Manufacturer Contact
herbert crane
2144 michelson drive
irvine, CA 92612
9495021907
MDR Report Key15373059
MDR Text Key299451895
Report Number3011649314-2022-00533
Device Sequence Number1
Product Code MQC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K121365
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Dentist
Type of Report Initial,Followup,Followup
Report Date 07/15/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/06/2022
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/01/2022
Initial Date FDA Received09/07/2022
Supplement Dates Manufacturer Received11/01/2022
09/01/2022
Supplement Dates FDA Received11/19/2022
07/15/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/17/2022
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Other;
Patient SexFemale
Patient RaceAsian
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