It was reported that the patient had a reaction to the 3d comfort splint that was issued.It is unclear when the patient received the device, when the patient first used the device, or when the reaction occurred or resolved.However, "tingling sensation under upper lip and tongue" are noted.
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Capa 2023-006 the device has not been returned.However, the non-visual device evaluation has been completed and the results are as follows: dhr results the dhr was reviewed for case#1118278058 and there was no evidence discovered to indicate that a product defect or non-conformity contributed to the issue.The receiving router for lot#mf1573 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 customer did not return the reported product for review to date.However, the non-visual device investigation has been completed.Root cause a root cause for this complaint cannot be explicitly determined.It is possible that reactions could be caused by mouthwash, toothpaste, or soaking material.However, the customer did not provide the information regarding how the patient handled and maintained the device.Ifu 12383 rev 3.0 (comfort3d bite splint) contains the following statement in the warning section: "use only clear, cool water to wash the device.A soft toothbrush may be used.Do not clean or soak in mouthwash.Do not use denture cleanser.Do not use hot water.Do not use alcohol or hydrogen peroxide.Do not place in direct sunlight.Keep away from heat sources." ifu 12383 rev 3.0 (comfort3d bite splint) contains the following statement for the cleaning procedures in the general safety and precautions section: "brush and floss your teeth before use.Rinse mouth well with clean water before inserting the nightguard.Rinse appliance well with clean, cool water before and after use.Clean comfort3d bite splint with clean, cool water only, and let it air dry." 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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