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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The balloon has hyperinflation.Symptomatic patient.The patient reported nausea, pain, and a lot of belching during consultation, endoscopy was performed, and hyperinflation was found.
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