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 kidney disease/toxicity, asthma and reduced cardiopulmonary reserve, hypersensitivity, inflammatory response, dizziness/headache, nausea/vomiting and nose, skin, eye and respiratory tract irritation.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.
|