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

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).

• 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 Key: 15396627
• MDR Text Key: 299670975
• Report Number: 3011649314-2022-00529
• Device Sequence Number: 1
• Product Code: MQC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183598
• Number of Events Reported: 1
• 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

• Date FDA Received: 09/09/2022
• 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 Manufacturer: 09/06/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/09/2022
• 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 Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 88 YR
• Patient Sex: Female
• Patient Weight: 66 KG
• Patient Race: White