MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS VERSATEX; MESH, SURGICAL, POLYMERIC

Model Number	VTX5050M
Medical Device Problem Codes	Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Event or Problem Description
According the reporter: the patient underwent an open sublay midline hernia procedure.After insertion the product had failed.The issue was detected with a ct scan.The patient will be re-operated on to correct the issue.The patient is alive.

• Brand Name: VERSATEX
• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): SOFRADIM PRODUCTION SAS; 116 avenue du formans; trevoux 01600 ; FR 01600
• MDR Report Key: 6890047
• Report Number: 9615742-2017-05359
• Device Sequence Number: 562093
• Product Code: FTL
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Type of Report: Initial
• Report Date (Section B): 08/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: VTX5050M
• Device Catalogue Number: VTX5050M
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2017
• Initial Report FDA Received Date: 09/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention