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 cpap device 's sound abatement foam.The patient has alleged hoarse voice, headache.The patient also alleged severe cough, dizzy and her nasal passage is always painful and tender since using the device.Device has strange odor.Device has not been returned to the manufacture for evaluation.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
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