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 asthma (new or worsening), nasal issues resulting in nasal turbinate surgery, worsening of type 2 diabetes, congestive heart failure, high blood pressure/worsening, sleep apnea, unconsciousness, heart failure, and confusion, in addition, increased blood glucose, sinus infections, eye infections, nose infections, upper airway infections, cough, chest pressure, chronic respiratory illness, hypersensitivity, oral cavity inflammation due to tooth extraction, nausea, vomiting, and headaches.There was no medical intervention 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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