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 dreamstation bipap pro device's sound abatement foam.The patient's attorney reporting allegations of eye irritation, nose irritation, skin irritation.Respiratory tract irritation, dizziness, headache, hypersensitivity, nausea, vomiting, asthma (new or worsening), inflammatory response, pneumonia.No other clinical information or medical interventions were reported.The device has not yet been returned to the manufacturer for investigation.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
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