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 an issue related to a bipap device's sound abatement foam.The patient has alleged of having nasal/throat irritation or soreness, lung irritation and also experienced pain from the device.There was no report of serious or permanent patient harm or injury.The manufacture's investigation is ongoing.A follow up report will be submitted when the manufacture's investigation is complete.
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