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 previously received patient information alleging development of squamous cell carcinoma and high-grade squamous dysplasia involving lymph nodes about jaw and tissue to the base of tongue related to a cpap device's sound abatement foam.There was no report of patient harm or injury.There is no customer information hence we cannot reach out to the customer and components returned for evaluation and investigation were unsuccessful.The manufacturer believes they will be unable to gather additional information. the manufacturer is submitting a final report at this time.If pertinent information becomes available to the manufacturer at a later date, an addendum to this final report will be filed.Section h6 updated in this report.
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