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.
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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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