(b)(4).Information was received from a surgeon who is not required to complete form 3500a.The product was not returned for evaluation, as it was implanted.The device was used for treatment.This issue has been previously investigated and as part of corrective action, a new supplier for the polyethylene bags has been selected and testing completed to ensure thermal reliability and stability of the new bags.This mdr was identified during an internal retrospective review to meet reporting requirements and therefore is being filed retrospectively.
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