ETHICON INC. PHYSIOMESH OVAL MESH, SURGICAL, POLYMERIC Back to Search Results Catalog Number PHY1520V Event Date 02/16/2015 Event Type Injury Manufacturer Narrative The initial procedure was an open procedure. The recurrent hernia was repaired with a different mesh. The surgeon opined a cause and contributing factor for the hernia recurrence was that "the patient had gained about 10 kilos after the hernia repair and the mesh was melt¿. Event Description It was reported that the patient underwent primary incisional anterior abdominal wall hernia repair procedure on (b)(6) 2013 and mesh was implanted. The mesh was placed using intraperitoneal onlay mesh technique. One month after the surgery, the patient was well. On (b)(6) 2014, the patient presented with incisional hernia in the same anatomical place. The patient underwent another surgical procedure on (b)(6) 2015. During the surgery, it was found that the mesh was not visible nor could the surgeon feel the mesh. The surgeon opined it was like it was melted and torn apart. It was reported the hernia sac was an enclave membrane which raised the hernia with the intestines also covered by peritoneum. Additional information has been requested. Manufacturer Narrative (b)(4). Date sent to the fda: 04/09/2015. (b)(4). No conclusion can be drawn at this time. Should additional information be obtained, a supplemental 3500a form will be submitted accordingly. In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria. 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 Key4672635 Report Number2210968201504167 Device Sequence Number1 Product CodeFTL24 Report SourceManufacturer Foreign,Health Professional,User facility,Company Source Type Representative https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4672635&pc=FTL
Reporter OccupationOther Type of ReportInitial,Followup Report Date03/30/2015 1 Device Was Involved in the Event 1 Patient Was Involved in the Event Date FDA Received04/09/2015 Is This An Adverse Event Report?Yes Is This A Product Problem Report?No Device OperatorHealth Professional Device Catalogue NumberPHY1520V Device LOT NumberGJ8CJPA0 Was Device Available For Evaluation?Yes Is The Reporter A Health Professional?No Was the Report Sent to FDA?No Date Manufacturer Received04/27/2015 Was Device Evaluated By Manufacturer?No Is The Device Single Use?Yes Is this a Reprocessed and Reused SingleUse No Device? Type of Device UsageInitial Patient TREATMENT DATA Date Received: 04/09/2015 Patient Sequence Number: 1
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