ETHICON INC. PHYSIOMESH RECTANGULAR MESH, SURGICAL, POLYMERIC Back to Search Results Catalog Number PHY2030R Event Date 04/23/2015 Event Type Injury Event Description It was reported that a patient underwent a ventral hernia repair on an unknown date and mesh was used on a patient with a relatively large defect. The patient required a reoperation and it was discovered by the surgeon that the mesh had ripped right down the middle. The surgeon had to repair the new hernia with another mesh. Additional information was requested. Manufacturer Narrative (b)(4). Conclusion: no conclusion can be drawn at this time. Should additional information be obtained, a supplemental 3500a form will be submitted accordingly. Search Alerts/Recalls22 New Search | Submit an Adverse Event Report23
Brand Name PHYSIOMESH RECTANGULAR 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 ContactMary Szaro Route 22 West Po Box 151 Somerville , NJ 08876 9082183464 MDR Report Key4779126 Report Number2210968201505950 Device Sequence Number1 Product CodeFTL24 Report SourceManufacturer Source TypeHealth Professional,User facility,Company Representative Reporter OccupationOther Type of ReportInitial Report Date04/24/2015 1 Device Was Involved in the Event 1 Patient Was Involved in the Event Date FDA Received05/18/2015 Is This An Adverse Event Report?Yes Is This A Product Problem Report?No Device OperatorHealth Professional Device Catalogue NumberPHY2030R https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4779126&pc=FTL
Was Device Available For Evaluation?No Is The Reporter A Health Professional?No Date Manufacturer Received04/23/2015 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: 05/18/2015 Patient Sequence Number: 1
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