The first fitting didn't go well because she had to rewarm it a second time and it got too soft and couldn't be refitted.The fitting of a second one went better, but was not completely successful and she was afraid to reheat it.She is hospitalized and using the second protector, but it still doesn't fit well.She also said the soft-shaped layer started to separate from the hard-based layer.
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This complaint has not been confirmed.Device not returned to 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, as choking is possible as a result of delamination.
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