(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed the voluntary user medwatch number is mw5059817.
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It was reported to boston scientific corporation that a y-mesh was used during an unknown procedure performed on (b)(6) 2015.According to the complainant, during the procedure and inside the patient, the physician noted a defect in the mesh so it was removed from the patient.There were no patient complications reported as a result of this event.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.
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