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 developed cancer and an edema.There was also an allegation from the patient stating issues with their lung, kidney and heart.The pms clinical expert determined that the allegations were not related to the recalled device.Medical intervention was not specified.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
|