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

Model Number	VTX1106
Medical Device Problem Codes	Degraded (1153); Product Quality Problem (1506)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during a left open inguinal hernia repair, while being applied into the groin the mesh was damaged.While the surgeon was cutting of the mesh the surgeon saw the mesh unravel at the cut edges and further reinforcement was required.Operative approach was to plug and patch.The size of the defect was 2.5 cm.The appearance of the mesh was normal before use, but after use, the mesh was fraying badly.To resolve the issue, another piece of mesh was used which resulted in the patient having three (3) mesh pieces implanted.The fixation used was sutures.No patient injury.

• 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: 7409950
• Report Number: 9615742-2018-00810
• Device Sequence Number: 1094879
• Product Code: FTL
• UDI-Device Identifier: 10884521532212
• UDI-Public: 10884521532212
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K150091
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 04/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2021
• Device Model Number: VTX1106
• Device Catalogue Number: VTX1106
• Device Lot Number: SQE0511X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2018
• Initial Report FDA Received Date: 04/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR