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 alleging fatigue, nasal dripping, dry eyes, watery eyes, red eyes, scratchy throat, headache, dizziness, nausea, shortness of breath, nasal congestion and cough.Patient also alleges it feels if the device is suffocating him.There is no allegation of serious or permanent harm or injury.No medical intervention was required by the patient.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
|