The manufacturer was contacted in reference to the voluntary field safety notice / recall notification related to the sound abatement foam in certain cpap, and mechanical ventilator devices.The manufacturer received information alleging visualization of particles and having nasal/throat irritation or soreness, sores in nose and eye was bleeding after dme gave medicine for eye infection.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
|
The manufacturer previously reported an allegation of an issue related to sound abatement foam.Additional information was received and section b5 should be reported as: 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 an issue related to a continuous positive airway pressure (cpap) device's sound abatement foam.There was no medical intervention required by the patient.The patient reports visualization of particles and alleging nasal/throat irritation or soreness, sores in nose and eye was bleeding after dme gave medicine for eye infection.The reported event of nasal/throat irritation or soreness, sores in nose and eye was bleeding after dme gave medicine for eye infection and its reported severity was reviewed by the manufacturer's clinical expert.This event is assessed as not related to the device in this case.Based on the available information, the manufacturer concludes no further action is necessary.There was no medical intervention required by the patient.The device has not yet returned to the manufacturer for evaluation.If any additional information is received, a follow up report will be filed.Section(s) b1, b2 are changed related to the complaint changing from the reported adverse event to a product problem.Section h1 is changed to reflect a malfunction.Section h6 health effect- impact code, type of investigation findings and investigation conclusions have been updated.
|