ETHICON INC. PHYSIOMESH OVAL MESH, SURGICAL, POLYMERIC Back to Search Results Catalog Number PHY1520V Event Date 10/16/2014 Event Type Injury Manufacturer Narrative (b)(4). Conclusion: to date, the device has not been returned. If the product is returned for evaluation, any further info derived from the evaluation will be submitted in a supplemental 3500a form. Manufacturer Narrative Conclusion: actual sample was returned for evaluation. Visual inspection was performed and no defects could be detected on this explanted piece of the mesh. No conclusion can be drawn at this time. Should additional information be obtained, a supplemental 3500a form will be submitted accordingly. Event Description It was reported that a patient underwent a robotic ventral hernia repair procedure in (b)(6) 2013 and mesh was implanted. The surgeon bridged the defect and did not do a primary closure. A ct scan performed (b)(6) 2014 showed the mesh remained intact. Another ct was performed (b)(6) 2014 and revealed a recurrence of the hernia. On (b)(6) 2014, the surgeon removed the mesh except for a small amount of the mesh that remained implanted and attached to the abdominal wall. The surgeon opines that something occurred and the mesh had pulled away from the tissue on one side. Search Alerts/Recalls22 New Search | Submit an Adverse Event Report23
Brand Name PHYSIOMESH OVAL Type of Device MESH, SURGICAL, POLYMERIC Manufacturer (Section D)ETHICON INC. P.O. Box 151, Route 22 West Somerville NJ 08876 015 Manufacturer (Section G)ETHICON INC.GMBH RobertKoch Strasse 1 Norderstedt D22 851 GERMANY D22851 Manufacturer ContactGuillermo Villa Route 22 West Po Box 151 Somerville , NJ 08876 9082180707 MDR Report Key4224037 Report Number2210968201415279 Device Sequence Number1 Product CodeFTL24 Report SourceManufacturer Source TypeHealth Professional,User facility,Company Representative Reporter OccupationOther Type of ReportInitial,Followup Report Date10/17/2014 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4224037&pc=FTL
1 Device Was Involved in the Event 1 Patient Was Involved in the Event Date FDA Received11/04/2014 Is This An Adverse Event Report?Yes Is This A Product Problem Report?No Device OperatorHealth Professional Device Catalogue NumberPHY1520V Was Device Available For Evaluation?Device Returned To Manufacturer Date Returned to Manufacturer11/24/2014 Is The Reporter A Health Professional?No Was the Report Sent to FDA?No Date Manufacturer Received11/25/2014 Was Device Evaluated By Manufacturer?Yes Is The Device Single Use?Yes Is this a Reprocessed and Reused SingleUse Device?No Type of Device UsageInitial Patient TREATMENT DATA Date Received: 11/04/2014 Patient Sequence Number: 1
Page Last Updated: 04/30/2017 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4224037&pc=FTL
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