5/29/2017
MAUDE Adverse Event Report: ETHICON INC. PHYSIOMESH OVAL MESH, SURGICAL, POLYMERIC
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MAUDE Adverse Event Report: ETHICON INC. PHYSIOMESH OVAL 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 OVAL MESH, SURGICAL, POLYMERIC Back to Search Results Catalog Number PHY2025V Event Date 09/08/2014 Event Type Death 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. In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria. Event Description It was reported that a patient underwent a laparoscopic hernia repair procedure on an unknown date and mesh was implanted. The second day after the surgery the patient developed adhesions to the intestinal loops and was admitted with septic shock and a distended abdomen with a peritoneal reaction. A laparotomy was performed. The surgeon found corrosion of the loops and perforation of the small intestine. Suture was used to close the intestines. A drain and reservoir were used. The intestinal fistula was surgically closed and the patient was hospitalized in the intensive care unit. Additional information was requested. Manufacturer Narrative (b)(4). It was reported that the patient had septic shock, possibly, originated by the fistula and the patient passed away. Manufacturer Narrative It was reported that the patient¿s cause of death was refractory septic shock, peritonitis. Manufacturer Narrative (b)(4). The patient was readmitted to the hospital for the reoperation on (b)(6) 2014. The patient is currently in a coma. Manufacturer Narrative On (b)(4) 2014, information was received that the patient was in a coma. On (b)(6) 2014, the patient passed away. Manufacturer Narrative It was reported that the initial procedure was performed (b)(6) 2014 and reoperation was performed on (b)(6) 2014. 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 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4115778&pc=FTL
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5/29/2017
MAUDE Adverse Event Report: ETHICON INC. PHYSIOMESH OVAL MESH, SURGICAL, POLYMERIC
Manufacturer ContactGuillermo Villa Route 22 West Po Box 151 Somerville , NJ 08876 9082180707 MDR Report Key4115778 Report Number2210968201413757 Device Sequence Number1 Product CodeFTL24 Report SourceManufacturer Source TypeForeign,Health Professional,User facility,Company Representative Reporter OccupationOther Type of ReportInitial,Followup,Followup,Followup,Followup Report Date09/22/2014 1 Device Was Involved in the Event 1 Patient Was Involved in the Event Date FDA Received09/24/2014 Is This An Adverse Event Report?Yes Is This A Product Problem Report?No Device OperatorHealth Professional Device EXPIRATION Date08/31/2015 Device Catalogue NumberPHY2025V Device LOT NumberGK8BBWA0 Was Device Available For Evaluation?Yes Is The Reporter A Health Professional?No Was the Report Sent to FDA?No Date Manufacturer Received03/09/2015 Was Device Evaluated By Manufacturer?No Date Device Manufactured09/01/2013 Type of Device UsageInitial Patient TREATMENT DATA Date Received: 09/24/2014 Patient Sequence Number: 1
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4115778&pc=FTL
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