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

Model Number	VTX5050M
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Torn Material (3024)
Health Effect - Clinical Codes	Hernia (2240); Radiation Exposure, Unintended (3164); No Information (3190); No Code Available (3191)
Date of Event	12/29/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
To date, the incident sample has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained, a follow-up report will be submitted.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, post-operatively, the unknown product, ventral mesh fracture.The issue was confirmed with computerized tomography.The surgery was performed.Patient status was unknown.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter: as per the additional information received, the product ventral mesh fracture.Fracture of the mesh resulted in hernia recurrence.The procedure was a hernia.The location of the hernia was ventral / incisional.Open transversus abdominis release operative approach / technique was performed.The size of the defect was 15x25cm.4x transfascial fixation sutures - pds fixation system was used.Four fixation points were applied.Mesh was not damaged during the procedure.Ct scan was done.An additional operation will be performed to correct the issue.Patient status : stable, with hernia recurrence.Pre-existing conditions and/or comorbidities for the patient : (b)(6), non-smoker, bmi 23.
Additional Manufacturer Narrative
Product analysis: examination: no product was provided for evaluation.A mesh seems to be visible and 2 ¿big¿ hernia holes are visible besides the mesh (one on the left and one on the right).Without the sample a detailed investigation could not be performed.If information is provided in the future, a supplemental report will be issued.

• 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: 7050118
• Report Number: 1219930-2017-08987
• Device Sequence Number: 9904191
• Product Code: FTL
• Combination Product (Y/N): N
• PMA/510(K) Number: K150091
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/19/2018

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: 10/31/2020
• Device Model Number: VTX5050M
• Device Catalogue Number: VTX5050M
• Device Lot Number: SPJ1016X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2018
• Initial Date Received by Manufacturer: 10/27/2017
• Supplement Date Received by Manufacturer: 11/20/2017; 01/16/2018
• Initial Report FDA Received Date: 11/21/2017
• Supplement Report FDA Received Date: 12/15/2017; 01/19/2018
• 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
• Patient Age: 70 YR