The manufacturer received information alleging a cpap device's sound abatement foam became degraded and caused colon cancer, heart arrythmia, deteriorating vision, rash and sore throat.The patient did receive medical intervention and reported to have had eye surgery.This issue was reported to the fda per 21 cfr 806.The device will be corrected per res 88058.
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The manufacturer previously reported an allegation of an issue related to sound abatement foam.Additional information was received and section b5 should be reported as: 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 an issue related to a continuous positive airway pressure (cpap) device's sound abatement foam.The patient alleged to experience colon cancer, heart arrythmia, deteriorating vision, rash and sore throat.There was no medical intervention required by the patient.The reported events of colon cancer, heart arrythmia, deteriorating vision, rash and sore throat and its reported severity was reviewed by the manufacture's clinical expert.These events are assessed as not related to the device in this case.Based on the available information, the manufacturer concludes no further action is necessary.The device has not yet returned to the manufacturer for evaluation and at this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.Sections b1, b2 has changed related to the complaint changing from the reported adverse event to a product problem.Section h1 has changed to reflect a malfunction.Section h6 health effect- impact code, type of investigation findings and investigation conclusions has been updated.
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