It was reported that the patient had a reaction (nausea) to the comfort hard soft splint.It is unclear when the patient received the device, when the patient first used the device, or when the reaction occurred.However, the device was worn for 3 consecutive nights.
|
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 the dhr was reviewed and there was no evidence discovered to indicate that a product defect or non-conformity contributed to the issue.Supplier (erkodent) reviewed the associated material lot and confirmed no material defects or changes could be detected.No manufacturing deviations or abnormalities are known.E-pro 4.0 - 11770201 (erkoloc-pro) was manufactured from november 17, 2021 and was assigned an expiration of november 2024.Stock product reviewed results no stock product was available for review since the device was fabricated per physician's prescription only.Investigation methods/results no device has been returned from the customer and no picture was provided by the customer to review.However, the non-visual device investigation has been completed.Root cause per the reported complaint, nausea may be a sign of an allergic reaction.Nausea irritant from splints is also a known side effect.A root cause for this complaint cannot be explicitly determined.No device has been returned for review.Ifu 9091 rev 5.0 (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".It is possible that reactions could be caused by mouthwash, toothpaste, or soaking material.
|