It was reported that the patient had a reaction to the comfort hard soft 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, it is noted that the patient experienced an abscess/ bump on gums.The device was worn for a few nights.There are no allergies 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 no lot number provided, dhr not completed.Stock product reviewed results no stock product was available for review since the device was fabricated per physician's prescription only.Investigation methods/results the customer has not returned the complaint part for investigation to date.However, the non-visual device investigation has been completed.Root cause a root cause for this complaint cannot be explicitly determined.Ifu 9091 rev 4.0 (comfort h/s 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".Glidewell research team and namsa conducted a series of testing on a similar thermoformed sleep device (haley) following iso 10993 (biological evaluation of medical devices) and the device was evaluated for potential cytotoxicity, skin irritation, delayed dermal contact sensitization and oral mucosal irritation.The haley test article was thermoformed with layers of erkodent material (erkoloc-pro and erkodur).The test results were listed below and summarized in biocompatibility report for haley sleep device (rpt 9733 rev 1.0) · for cytotoxicity testing, the test article extract showed no evidence of causing cell lysis or toxicity.· for skin irritation, there was no erythema and no edema observed on the skin of the animals treated with the test article.· for sensitization testing, the test article extracts showed no evidence of causing delayed dermal contact sensitization.· the test article showed nonirritant to the oral mucosa as compared to the control article.The device materials have been found to be biocompatible through the testing.There was no cytotoxic, sensitization, skin irritation, or oral mucosal irritation found in any of the test articles.
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