The reported device was not available for an evaluation.Without the device, physical structure testing cannot be completed; however, tests were performed on a similar device.The reported mouthguard was fabricated per physician's prescription request.A review of the material lot was performed and no non-conformity was found.A series of biocompatibility tests were performed on a similar thermoformed mouthguard.It was found that the sleep device materials are biocompatible.Cytotoxicity test was completed on the test article and there was no evidence of toxicity nor cell lysis.There was no evidence of erythema and no edema observed for skin irritation test.Sensitization test showed no evidence of the test article causing delay dermal contact nor oral mucosal irritation.Although the root cause for the allergic reaction could not be explicitly determined, a probable cause could be an allergy to the metal.Per the provided information, it was reported that the patient might have metal allergies.While the appliance hardware has a very low nickel composition (3-5%), there is a possibility of developing an allergic reaction in people with existing sensitivity.In this case, the patient might have a pre-existing allergy to metal.There were no device problems found.This incident is being monitored, tracked, and trended.
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