ETHICON INC. PHYSIOMESH OVAL MESH, SURGICAL, POLYMERIC Back to Search Results Catalog Number PHY1520V Device Problem No code available Event Date 09/14/2015 Event Type Injury Manufacturer Narrative (b)(4). Conclusion code: 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. Event Description It was reported that the patient underwent an incisional hernia surgical procedure on (b)(6) 2014 and mesh was implanted. Following the procedure, the patient experienced a recurrent hernia and underwent a surgical procedure with exploratory laparotomy this week. The mesh that had contact with the strap was absorbed by the visceral peritoneum and intestinal fibro saram. Additional information has been requested. 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 0151 Manufacturer (Section G)ETHICON INC.GMBH RobertKoch Strasse 1 Norderstedt D228 51 GERMANY D22851 Manufacturer ContactGuillermo Villa Route 22 West Po Box 151 Somerville , NJ 08876 9082180707 MDR Report Key5118197 Report Number2210968201514378 Device Sequence Number1 Product CodeFTL24 Report SourceManufacturer Source TypeCOMPANY REPRESENTATIVE,FOREIG Reporter OccupationOther Type of ReportInitial Report Date09/22/2015 1 Device Was Involved in the Event 1 Patient Was Involved in the Event Date FDA Received10/01/2015 Is This An Adverse Event Report?Yes Is This A Product Problem Report?No Device OperatorHealth Professional https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5118197&pc=FTL
Device Catalogue NumberPHY1520V Was Device Available For Evaluation?Yes Is The Reporter A Health Professional?No Was the Report Sent to FDA? Event LocationNo Information Date Manufacturer Received09/14/2015 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: 10/01/2015 Patient Sequence Number: 1
15.10 5118197, PHY1520V Absorbed by Visceral Peritoneum ...
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