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 particles in the device and airway.The patient alleges headache, nasal/throat irritation or soreness, chest pains.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.
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