Note: the initial information was provided through a patient report.The patient provided the name of the implanting surgeon and gave allergan consent to follow up with the surgeon.Allergan conducted follow up activities with the (b)(6) medical center.Conclusion: the device was not returned to allergan for evaluation.Multiple attempts are made to retrieve additional clinical information concerning the event, including confirmation of the patient conditions with the implanting physician, including co-morbidities, medical and surgical history, complications, course of treatment, and outcome.After following up, the general surgery consulting nurse at the surgical site reported that the implanting surgeon is on indefinite administrative leave and no relevant clinical follow up information is available.Our internal investigation of lot s11033 includes a review of the reported information, a review of the device history records, and a review of the complaint history records.The review of processing history records for lot s11033 was unremarkable.The lot was aseptically processed and terminally sterilized within process parameters.There were no processing deviations or nonconformance related to the nature of this complaint.No other complaint has been reported to allergan against lot s11033.As of 07 september 2018, of the (b)(4) devices released to finished goods for lot s11033, (b)(4) devices were distributed with (b)(4) devices reported to be implanted.Based on our internal review, lot s11033 met qc criteria for release.Should additional information be reported, a follow up adverse event report will be submitted; otherwise this investigation is concluded.
|
It was reported to allergan by a (b)(6) female patient that she had undergone a laparoscopic surgery on (b)(6) 2012 with strattice.The patient reports that she experienced postoperative complications that include acid reflux, "loss of voice," lack of sleep, and "three major surgeries and five procedures due to the mesh attaching to the liver and closing the stomach." according to her report, the procedures involved "balloon dilations to open the area," and surgical procedures to cut a piece of the mesh in (b)(6) 2013 and to remove the mesh less than a year afterwards.
|