This complaint has not been confirmed.The device has not been returned to the manufacturer, and no lot number information was given so an evaluation cannot be performed as to the root cause or actual nature of the problem.No injury was reported, no medical attention was reported to have been sought.This is being reported as a possible delamination, and medical intervention may be required if the device is swallowed and goes beyond the pharyngeal arch.It appears that the consumer did not mold the device according to the instructions.
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