It was reported that the patient had a reaction to the ema 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 experiencing burning sensation on tongue and buccal mucosa.The device was worn for 2-3 weeks (exact dates unknown).The symptoms went away after a few days of non-use (exact date unknown).Per the information there are no medical or dental history noted.
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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 for case#1119471819 and there was no evidence discovered to indicate that a product defect or non-conformity contributed to the issue.Supplier (garreco) reviewed the associated material lot and confirmed no manufacturing deviation or abnormality.(see attachment) acrylic: lot# 940122 was manufactured from january 2022 and was assigned an expiration of january 2027.Supplier (myerson) reviewed the associated material lot and confirmed no manufacturing deviation or abnormality.(see attachment) disk: lot# td091522 was manufactured from september 15, 2022 and was assigned an expiration of september 15, 2023.Button: lot# bn2b053022 was manufactured from may 30, 2022 and was assigned an expiration of may 30, 2025.Bite pad: lot# b053022 was manufactured from may 30, 2022 and was assigned an expiration of may 30, 2025.Strap: lot# sa260360 was manufactured from june 16, 2022 and was assigned an expiration of june 16, 2025.Supplier (keystone) reviewed the associated material lot and confirmed no manufacturing deviation or abnormality.(see attachment) monomer: lot#mc8891 was manufactured from february 23, 2022 and was assigned an expiration of february 23, 2025.Stock product reviewed results no stock product was available for review since the device was fabricated per physician's prescription only.Investigation methods/results customer has not returned the product or provided an image for review.However, the non-visual device investigation has been completed.Root cause a root cause for this complaint cannot be explicitly determined.It is possible that reactions could be caused by mouthwash, toothpaste, or soaking material.However, the customer did not provide the information regarding how the patient handled and maintained the device.The patient has a history of sleep apnea, sinus issues, and an artificial joint (specific site unknown).Ifu-012544_3: dentists should consider the medical history of the patients, including allergic reactions, history of asthma, breathing, or respiratory disorders, or other relevant health problems and refer the patient to the appropriate healthcare provider before prescribing the device.Irritation of the mouth, tongue, and lips may occur.Regular dental follow-ups are recommended to review any side effects to avoid device breakage, allergic reaction, irritation, or discomfort.Ifu-012544_3 - cleaning procedures · brush and floss 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.· brush the device carefully with a soft toothbrush and use only clear cool water to rinse the device.· do not use soap to clean appliance.· minimize odor by letting the device dry during the day with the container lid open.Additional information: a2 age at time if event, date of birth, a3 sex, a4 weight, a6 race.
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