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 painful sores forming in the mouth from using the device.There is no allegation of serious or permanent harm or injury.The patient required no medical intervention.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
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