5/28/2017

MAUDE Adverse Event Report: ETHICON, INC> PHYSIOMESH MESH SURGICAL POLYMERIC

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MAUDE Adverse Event Report: ETHICON, INC> PHYSIOMESH MESH SURGICAL POLYMERIC |Adverse |Recalls11 |PMA12|HDE13|Classification14|Standards15 6510(k) 7|DeNovo8|Registration & 9 10 Listing Events CFR Title 2116 |Radiation­Emitting Products17|X­Ray Assembler 18|Medsun Reports19|CLIA20|TPLC21

ETHICON, INC> PHYSIOMESH MESH SURGICAL POLYMERIC Back to Search Results Event Type  Injury   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. Event Description It was reported that a patient underwent an open ventral hernia repair on an unknown date and mesh was implanted. Approximately four months post operatively, the patient experienced a recurrent hernia. A re­operation was performed. During the surgery it was noted that the mesh was torn in the middle. Additional information to be requested. Search Alerts/Recalls22 New Search  |  Submit an Adverse Event Report23

Brand Name PHYSIOMESH Type of Device MESH SURGICAL POLYMERIC Manufacturer (Section D)ETHICON, INC> Route 22 West Po Box 151 Somerville NJ 08876 Manufacturer (Section G)ETHICON GMBH & COMPANY KG Robert ­ Koch ­ Strasse 1 Po Box 1409 D­22851 Norderstedt GERMANY Manufacturer ContactKathy Rice 4545 Creek Road Mail Location 120 Cincinnati , OH 45242 5133373299 MDR Report Key3058421 Report Number2210968­2013­03914 Device Sequence Number1 Product CodeFTL24 Report SourceManufacturer Source TypeHealth Professional,User facility,Company Representative Reporter OccupationPhysician Remedial ActionOther Type of ReportInitial Report Date03/18/2013 1 Device Was Involved in the Event 1 Patient Was Involved in the Event Date FDA Received04/15/2013 Is This An Adverse Event Report?Yes Is This A Product Problem Report?No Device OperatorHealth Professional Was Device Available For Evaluation?No https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3058421&pc=FTL

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5/28/2017

MAUDE Adverse Event Report: ETHICON, INC> PHYSIOMESH MESH SURGICAL POLYMERIC

Is The Reporter A Health Professional?Yes Event LocationOther Date Manufacturer Received03/18/2013 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: 04/15/2013 Patient Sequence Number: 1

Page Last Updated: 04/30/2017

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3058421&pc=FTL

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