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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PRISMATIK DENTALCRAFT, INC. COMFORT 3D; THERMOFORM MOUTHGUARD

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PRISMATIK DENTALCRAFT, INC. COMFORT 3D; 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 07/08/2022
Event Type  Injury  
Manufacturer Narrative
The device has been returned.Once the investigation is complete a supplemental report will be submitted.This is the second of two implant complaints, see manufacturer report for the remaining complaint : 3011649314-2022-00500.
 
Event Description
It was reported that the patient had a reaction to the comfort 3d splint that was issued.The device was issued on (b)(6) 2022 and used that evening and the reaction occurred (b)(6) 2022.The patient experienced "cough, excessive mucous which caused gagging." the patient discontinued using the device for two (2) nights.The reaction resolved 48 hours after discontinuation.The device was worn again (exact date unknown) with the same reaction occurring.The patient has many numerous allergies (see list).There was an allergy consult in 2019, but nothing recent.With regards to the device: the provider rinsed the device with water as did the patient.The device has been requested and is available for return.
 
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.The receiving router for lot# mc0469 indicated printer resin from keystone industries (supplier) passed inspection and met the specification.C of a (certificate of analysis) was also provided and confirmed the material was qualified for release.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.Comfort3d bite 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 did not show any signs of discoloration.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".Per the reported information, the patient has a history of depression and an allergy to trelegy, pneumovax and cipro prozac, celebrex, aspirin, biotin, calcium carbonate, flonase, vitamin d, ketotifen, and glucosamine.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).
 
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Brand Name
COMFORT 3D
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 Key15396627
MDR Text Key299670975
Report Number3011649314-2022-00529
Device Sequence Number1
Product Code MQC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K183598
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Dentist
Type of Report Initial,Followup
Report Date 12/06/2022
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? Yes
Device Operator Health Professional
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 08/16/2022
Initial Date FDA Received09/09/2022
Supplement Dates Manufacturer Received09/09/2022
Supplement Dates FDA Received12/06/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age88 YR
Patient SexFemale
Patient Weight66 KG
Patient RaceWhite
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