The device was returned, but did not transfer to the investigator.However, the non-visual device investigation has been completed and the results are as follows: device history record no dhr was available for review since the device was fabricated per physician's prescription only.Stock product reviewed: no stock product was available for review since the device was fabricated per physician's prescription only.Returned sample: the device was returned, but did not transfer to the investigator.Investigation results: the device was returned, but did not transfer to the investigator.Root cause: a root cause for this complaint cannot be explicitly determined.Ifu 7322 rev 2.0 (silent nite sleep appliance instructions for use) provides warning in precautions "do not soak the device in mouthwash; denture cleanser, hot water or alcohol; do not wash the device with soap, toothpaste or mouthwash; do not dry the device with a blow dryer; do not store in direct sunlight".However, the customer did not provide the information regarding how the patient handled and maintained the device.Glidewell research team and namsa conducted a series of testing on a similar thermoformed sleep device 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 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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