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 eye-skin-respiratory tract irritations, dizziness and/or headache, hypersensitivity, nausea, vomiting, asthma, ear-nose-throat inflammations, reactive airway disease, and acute respiratory distress system.Medical interventions were not specified.The manufacturer was made aware of this complaint through a representative of the customer.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
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