(b)(4).Only event year known: 2020.Batch # unk.The lot/batch was not provided; therefore, the manufacturing record evaluation could not be performed.Additional information received: additional 6 leaks were anecdotally reported by the surgeon as the rep was investigating another reported product complaint.The surgical team has a dedicated team for firing the device.These 6 cases were not the cases of dr.(b)(6).There surgeon could not provide additional details such as, surgeon, patient demographics or additional event details.It could not be determined what device was used in any of these procedures (cdh, ecs, or powered circ).Account is a long time ethicon account.Based on the information provided, there is no evidence that the devices used caused or contributed to the reported event.If information is obtained that was not available for the initial report, a follow-up report will be field as appropriate.
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