MAUDE Adverse Event Report: JOHNSON & JOHNSON INTERNATIONAL PHYSIOMESH MESH, SURGICAL
I . More Information at https://hollislawfirm.com/case/hernia-mesh-lawsuit/physiomesh/
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MAUDE Adverse Event Report: JOHNSON & JOHNSON INTERNATIONAL PHYSIOMESH MESH, SURGICAL |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
JOHNSON & JOHNSON INTERNATIONAL PHYSIOMESH MESH, SURGICAL Back to Search Results Device Problems Failure to Adhere or Bond; No code available Event Date 11/24/2016 Event Type Injury Manufacturer Narrative (b)(4). To date the device has not been returned. If the device or further details are received at a later date a supplemental medwatch will be sent. Event Description It was reported that the patient underwent an unknown procedure on unknown date and the mesh was implanted. Following the procedure, the patient underwent a revision procedure due to recurrent hernia and the mesh was found in half down the middle where bowel was. It was also reported that abdominal wall ingrowth was low compared to other mesh. It was not reported what the device was used to replace the mesh. 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)JOHNSON & JOHNSON INTERNATIONAL Leonardo Da Vincilaan 15 Diegem 1831 BELGIUM 1831 Manufacturer (Section G)ETHICON INC.GMBH RobertKoch Strasse 1 Norderstedt D228 51 GERMANY D22851 Manufacturer ContactKrystina Laguna Route 22 Westp O Box 151 Somerville , NJ 08876 9082183043 MDR Report Key6168117 Report Number2210968201660103 Device Sequence Number1 Product CodeFTL24 Report SourceManufacturer Source TypeCOMPANY REPRESENTATIVE,FOREIG Reporter OccupationOther Type of ReportInitial Report Date11/24/2016 1 Device Was Involved in the Event 1 Patient Was Involved in the Event Date FDA Received12/12/2016 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=6168117&pc=FTL
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MAUDE Adverse Event Report: JOHNSON & JOHNSON INTERNATIONAL PHYSIOMESH MESH, SURGICAL
Was Device Available For Evaluation?No Is The Reporter A Health Professional?No Was the Report Sent to FDA? Event LocationNo Information Date Manufacturer Received11/24/2016 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: 12/12/2016 Patient Sequence Number: 1
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