The manufacturer received information alleging an issue related to a cpap device's sound abatement foam.The user alleges health complications including diabetes, inflammation, leukocytosis, and hypertension.No serial number or model number were provided.This issue was reported to the fda per 21 cfr 806.The device will be corrected per res 88058.
|
The manufacturer previously reported an allegation of an issue related to sound abatement foam.There was no report of serious patient harm or injury.In initial reports section b5 mentioned incomplete, correct b5 should be: 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 diabetes, nausea and vomiting, dysphagia gerds, acute inhalation, headaches, coughs, esophagitis, htn, toxic and carcinogenic effect, inflammation, and fluid build up lung leukocytosis, pain suffering, emotional distress, loss of enjoyment, and loss of consortium.Needing tacheometry surgery related to a cpap device's sound abatement foam.There is no customer information hence we cannot reach out to the customer 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 is updated in this report.Section h6(clinical code) is corrected in this report.
|