The manufacturer previously reported blister in her throat and in her mouth, the blisters are bleeding with the device's sound abatement foam.The manufacturer received additional information alleging sinius infections, wheezing, headaches, eye and nose irriation.There was no allegation of serious or permanent harm or injury.
|
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 previously received information alleging patient has sinius infections, wheezing, headaches, eye and nose irriation, blister in her throat and in her mouth the blisters are bleeding related to a bipap device's sound abatement foam.There was no report of patient harm or injury.Repeated attempts to have the device and components returned for evaluation and investigation were unsuccessful.The manufacturer believes they will be unable to gather additional information.The manufacturer is submitting a final report at this time.If pertinent information becomes available to the manufacturer at a later date, an addendum to this final report will be filed.Section h6 updated in this report.
|