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 of patient alleging kidney disease/toxicity and renal failure.There is no allegation of serious or permanent harm or injury.No medical intervention was required by the patient.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
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On the previously submitted report, adverse event/product problem and outcomes attributed to ae in section b, health impact, type of reported complaint and recall number were incorrect. it is corrected on this report.In addition, medical intervention was not specified.Due to no device information being provided, the exact recall number is unknown, therefore the most likely recall number is reported on this report.
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