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 auto cpap device's sound abatement foam.The patient alleged eye irritation, nose irritation, skin irritation,rrespiratory tract irritation, dizziness and/or headache, nausea / vomiting, liver disease/toxicity, persistent cough, chest pressure, dry throat, fatigue, blood urine.No further clinical details or medical intervention were reported.Due to potential litigation surrounding this case, no follow up can be performed at this time.If any additional information is received, a follow up report will be filed.
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