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 cpap device's sound abatement foam.The patient has alleged eye irritation, nose irritation, skin irritation, respiratory tract irritation, dizziness, headache, hypersensitivity, nausea, vomiting, asthma (new or worsening), inflammatory response, cancer, high blood pressure.The manufacturer's investigation is ongoing.A follow up report will be submitted when the manufacturer's investigation is complete.
|