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 "dry eyes and sinus infections when using the device".There is no allegation of serious or permanent harm or injury.No medical intervention was required by the patient.The device was returned to the manufacturer, but the investigation has not yet begun.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
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