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 nose irritation, respiratory tract irritation, dizziness and/or headache, inflammatory response, sinus headaches, sneezing, and pain behind the eyes.There is no allegation of serious or permanent harm or injury.No medical intervention was required by the patient.There is no customer information hence we cannot reach out to the customer and components returned for evaluation and investigation were unsuccessful.The manufacturer believes they will be unable to gather additional information.If additional information becomes available, a supplemental report will be filed.
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