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 that the patient reported severe ear inflammation, severe eye inflammation, severe nose inflammation, severe oral cavity inflammation, severe sinus inflammation, and severe throat inflammation.Medical intervention was not specified.There is no allegation of serious or permanent harm or injury.The manufacturer was made aware of this complaint through a representative of the customer.The device has not yet been returned to the manufacturer for evaluation and there is no contact information for the initial reporter to gain additional information on the device.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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