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

Model Number VTX5050M

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Injury (2348); No Code Available (3191)

Event Date 03/01/2017

Event Type  Injury  

Manufacturer Narrative

Medtronic complaint number: pe:(b)(4).

Event Description

According to the reporter, post-operatively, the device was used in an abdominal wall reconstruction tar wherein the patient incurred a temporary injury, having a recurrent incisional hernia.The location of the hernia was midline defect.The size of the defect was 23cm which was closed after the procedure by suture.Future surgery will be required in order to resolve the issue.

• 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: 6772319
• MDR Text Key: 82004985
• Report Number: 9615742-2017-05198
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VTX5050M
• Device Catalogue Number: VTX5050M
• Device Lot Number: SPJ0706X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/18/2017
• 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): Hospitalization; Required Intervention
• Patient Age: 53 YR
• Patient Weight: 64