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 coughs up blood every day at night, ear pressure and itchy throat.There is no allegation of serious or permanent harm or injury.Medical intervention was not specified.At this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.
|