Pursuant to title 21 - food and drugs, chapter i - food and drug administration department of health and human services, subchapter h -0 medical device, part 803 - medical device reporting, subpart a - general provisions, section 803.16, neither this report nor any information submitted herein constitutes an admission by caire inc.That the device stated in this report, caire inc., or caire inc.'s employees, caused or contributed to the reportable event stated herein.The unit will not be returned for an evaluation.The patient was smoking while using the concentrator.The user manual contains warnings to not smoke while using the device.
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On october 4, 2022, caire received a voluntary medwatch form from vitas healthcare for the below incident: the patient was smoking with o2 on.The patient was transported to the hospital with second degree burns to the bilateral hands, nose, and nares.
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