The manufacturer was contacted in reference to the voluntary field safety notice / recall notification related to the sound abatement foam in certain cpap and mechanical ventilator devices.The manufacturer received information alleging headaches, swelling to face, numbness of limbs, ringing in ear, nausea, and sore throat.There was no serious or permanent patient harm or injury.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
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The manufacturer previously reported an allegation of an issue related to sound abatement foam.Upon further review, this device was a repaired device and did not contain sound abatement foam that would be likely to cause or contribute to death or serious injury and is not in scope of res 88058.Therefore, there is no allegation of a reportable event associated with the device at this time.
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