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 voluntary medwatch (mw5106456).The manufacturer received information alleging an issue related to a cpap device's sound abatement foam.The patient has alleged sinus problems, insomnia, rashes, fatigue, sinus congestion, edema and swelling, headaches and patient had 2 or 3 rounds of antibiotics, steroids and nasal sprays for her sinuses during this time.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.
|