ETHICON INC. PHYSIOMESH MESH, SURGICAL Back to Search Results Catalog Number PHY2025R Event Date 07/14/2014 Event Type Injury Manufacturer Narrative (b)(4). 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 the patient underwent incisional hernioplasty in (b)(6) 2014 and mesh was implanted. Four months following the procedure, the patient experienced enterocutaneous fistula and bowel perforation which drained fecal matter without exposure of mesh. The fistula had already occurred but was not reported since surgeon opined that obstruction of the hemovac and high risk factor of the patient contributed to the fistula. On (b)(6) 2014, the patient underwent another procedure for bowel perforation and a surgical washing of cavity was performed. During the procedure, it was observed the fistula and the mesh almost integrated within a short period of time. Additional information has been requested. Search Alerts/Recalls22 New Search | Submit an Adverse Event Report23
Brand Name PHYSIOMESH Type of Device MESH, SURGICAL 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 Key3979789 Report Number2210968201410774 Device Sequence Number1 Product CodeFTL24 Report SourceManufacturer Source TypeForeign,Health Professional,Company Representative Reporter OccupationOther Type of ReportInitial Report Date07/16/2014 1 Device Was Involved in the Event 1 Patient Was Involved in the Event Date FDA Received08/05/2014 Is This An Adverse Event Report?Yes Is This A Product Problem Report?No https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3979789&pc=FTL
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MAUDE Adverse Event Report: ETHICON INC. PHYSIOMESH MESH, SURGICAL
Device OperatorHealth Professional Device Catalogue NumberPHY2025R Was Device Available For Evaluation?No Is The Reporter A Health Professional?No Date Manufacturer Received07/14/2014 Was Device Evaluated By Manufacturer?Device Not Returned To Manufacturer Is The Device Single Use?Yes Is this a Reprocessed and Reused SingleUse Device?No Type of Device UsageInitial Patient TREATMENT DATA Date Received: 08/05/2014 Patient Sequence Number: 1
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