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 alleges headache, tongue swelling, bleeding in mouth, throat irritation, and body aches.There is no allegation of serious or permanent harm or injury.No medical intervention was required by the patient.The manufacturers investigation is ongoing.A follow-up report will be submitted when the manufacturers investigation is complete.
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