The device has not yet been returned.An investigation will be conducted once the sample has been returned and a supplemental report will be submitted.Weight: asked, but unknown.Date of event: asked, but unknown.Model number: not applicable.Catalog number: not applicable.Lot number: not applicable.Expiration date: not applicable.Udi number: not available.
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The device investigation has been completed and the results are as follows: dhr results no dhr was available for review since the device was fabricated per physician's prescription only.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 and both upper and lower tray were returned with original case.The results were summarized below: roughness - the edge was smooth.Crack - no major cracks were found.Delamination - layers were intact and did not separated.Discoloration - no discoloration was observed.General cleanliness - the device was clean.Case was returned in a good condition with label.Accessories - the connector and bite tabs were all intact.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.The returned device had no defect and there was no evidence indicating the reactions were contributed by the device.The device materials have been found to be biocompatible through the testing.There was no cytotoxic, sensitization, skin irritation, or oral mucosal irritation found per (rpt 9733 rev 1.0).
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