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 from the patient alleging that the patient has nose irritation, skin irritation, respiratory tract irritation, dizziness and/or headache, hypersensitivity, nausea / vomiting, kidney disease/toxicity.No medical intervention was specified.Due to potential litigation surrounding this case, no follow up can be performed at this time.At this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.
|