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

Model Number	VTX4530M
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hernia (2240); No Code Available (3191)
Date of Event	02/11/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, 10 months ago, robot assisted laparoscopy was performed and the mesh was placed to repair the ventral hernia.Postoperatively, at the epigastric, umbilical, and infraumbilical part on a laparoscopic robot assisted ventral hernia repair, the mesh had a 13cm by 27cm defect.The patient had a recurrent hernia through the mesh 10 months after implantation.The patient had to be hospitalized again for a second operation via laparoscopic intraperitoneal onlay mesh to repair the recurrent hernia.

• 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: 9756293
• Report Number: 9615742-2020-00454
• Device Sequence Number: 2184893
• Product Code: FTL
• UDI-Device Identifier: 10884521532274
• UDI-Public: 10884521532274
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K150091
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/26/2020

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 Expiration Date: 12/31/2023
• Device Model Number: VTX4530M
• Device Catalogue Number: VTX4530M
• Device Lot Number: STA1962X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2020
• Initial Report FDA Received Date: 02/26/2020
• 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: Hospitalization; Required Intervention
• Patient Age: 64 YR
• Patient Weight: 110