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 asthma (new or worsening) and lung disease.In addition, the patient also reported nose and respiratory tract irritation, inflammatory response, dizziness, headache, nausea and vomiting.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.
|