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 patient is alleging nose irritation, respiratory tract irritation, dizziness and/or headache, hypersensitivity, nausea and vomiting.There was no serious patient harm or injury.At this time, no medical intervention has been reported.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
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