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 alleged nose irritation.In addition, the patient also reported skin irritation, dizziness, chest pain, shortness of breath, migraines and headache.There was no report of serious patient harm or injury.Due to potential litigation surrounding this case, no follow up can be performed at this time.At this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.
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