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 rashes, redness on the cheekbones and on the bottom of the forehead (just above the eyebrows) "very regularly, not to say almost continuously" since the past 2-3 years.The patient states that the redness was accompanied at first by a sensation of slight burning, which evolved towards a scaling of the skin in said areas.There is no allegation of serious or permanent harm or injury.The device has been returned to a third-party service center and the investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
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