I enclose with this letter 2 night-time protectors.After wearing each one for seven hours, the areas under the bite pads had formed a bubble or blister effect.When i cleaned them, the raised areas filled with water because each had worn through the other bottom layer, allowing a space for bacteria to form.
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After receipt of the product for investigation, it appears that there is no "bubbling" or voids in the device.This device was molded correctly.The device seems to have been extensively chewed up after the stated "one use" causing the softer bite pad material to be separated from the base material.This device is intended for mild to moderate bruxism, not the severe bruxism of which it appears to have been subjected.This report has not been confirmed, no injury was reported, and no medical attention was sought.This is being reported even though the device was used outside the intended use indicated on the labeling.Chewed up pieces of this device can be aspirated which could cause an injury requiring surgical intervention.
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