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 states he never noticed particles in the device.The patient alleges sneezing badly.There is no allegation of serious or permanent harm or injury.The patient required no medical intervention.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
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The manufacturer previously reported information 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 states he never noticed particles in the device.The patient alleges sneezing badly.There is no allegation of serious or permanent harm or injury.The patient required no medical intervention.Upon further investigation, the information received from the patient shows the harms are from past medical history and does not support the device having contributed to the alleged serious injury.If any additional information is received, a follow-up report will be filed.
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