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

Model Number VTX5050M

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Torn Material (3024)

Patient Problems Hernia (2240); Radiation Exposure, Unintended (3164); No Information (3190); No Code Available (3191)

Event Date 12/29/2016

Event Type  Injury  

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 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.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event 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.

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
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): SOFRADIM PRODUCTION SAS; 116 avenue du formans; trevoux 01600 ; FR 01600
• Manufacturer (Section G): SOFRADIM PRODUCTION SAS; 116 avenue du formans; trevoux 01600 ; FR 01600
• Manufacturer Contact: sharon murphy ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 7050118
• MDR Text Key: 92667261
• Report Number: 1219930-2017-08987
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150091
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/27/2017
• Initial Date FDA Received: 11/21/2017
• Supplement Dates Manufacturer Received: 11/20/2017; 01/16/2018
• Supplement Dates FDA Received: 12/15/2017; 01/19/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/19/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 70 YR