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 patient alleges " using the device it cause her skin to break out leaving little white dots on her face" the patient stated, "headaches, shortness of breath, neck pain.Trying to go off the device because of the recall triggered a lot of symptoms for her.She did have symptoms while using the device as well.She is not sure if her symptoms correlate with the use of the cpap or if it is something else and will seek care from her doctor.She has been hospitalized due to not being able to use her cpap during this time".There is no allegation of serious or permanent harm or injury.No medical intervention was specified as required by the patient.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
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