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 of inflammatory response, kidney disease/toxicity, liver disease/toxicity, lung disease, pleural effusion and respiratory failure.The manufacturer was made aware of this complaint through a representative of the customer.There was no medical intervention required by the patient.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
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