The manufacturer was contacted in reference to the voluntary field safety notice/recall notification related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.The manufacturer received information alleging an issue related to a remstar auto a-flex device's sound abatement foam.The patient has alleged dizziness, headache, pancreatic injury, difficulty breathing.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
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