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 a patient copd, pulmonary fibrosis, other pulmonary damage/inflammatory response, prostate cancer, thyroid nodules kidney cyst, focal bronchiectasis and superimposed cystic changes note in the posterior right upper lobe due to the device.There is allegation of serious or permanent harm or injury.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
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