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

Model Number	VTX3030M
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Title: enhanced-view totally extraperitoneal approach in emergency ventral incision hernia repair: a case report source: swiss med wkly.2021;151:w20423 pp1-4.(b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to literature source of study performed in 2021, 30 days post-operative to emergency laparoscopic ventral hernia repair via enhanced-view totally extraperitoneal (etep) approach, there was a symptomatic seroma causing pain in the surgical site, which needed surgical evacuation, but was completely resolved at 1-year follow-up with no symptoms at all.

• 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: 12661865
• Report Number: 9615742-2021-02335
• Device Sequence Number: 4530854
• Product Code: FTL
• UDI-Device Identifier: 10884521532267
• UDI-Public: 10884521532267
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K150091
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,l
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/19/2021

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: VTX3030M
• Device Catalogue Number: VTX3030M
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2021
• Initial Report FDA Received Date: 10/19/2021
• 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: Required Intervention
• Patient Age: 57 YR