In (b)(6) 2024, the patient presented significant abdominal pain with a diagnosis of balloon hyperinflation (x-ray attached).The 500ml balloon was readjusted.On (b)(6) 2024 the patient presented a new condition of abdominal pain with new hyperinflation of the balloon, which was removed on (b)(6) 2024 to avoid possible complications.
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To date, spatz fgia inc.Has not received the product for evaluation, therefore no analysis or testing has been done.A review of the device labeling notes the following: spontaneous hyperinflation is the enlargement of the balloon with extra air that can occur spontaneously.This can lead to symptoms such as pain, nausea, vomiting, dehydration, ulceration, perforation, and could require a down adjustment or removal of the balloon.
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