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 respiratory tract irritation, asthma (new or worsening), kidney disease/ toxicity, lung disease, bladder cancer, stomach infection, metastasized to his/her kidney and death on (b)(6) 2021.There was no report of medical intervention.No additional information can be requested at this time.The manufacturer was made aware of this complaint through a representative of the customer.At this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.
|