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

Model Number SYM8OS

Device Problem Material Erosion (1214)

Patient Problems Tissue Damage (2104); No Code Available (3191)

Event Date 03/26/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4). Evaluation summary: one device was returned for investigation. A review of the device history record has been performed and no failure that may relate to the reported conditions have been noted. Especially the records related to the collagen casting and the collagen based film results and the mechanical testing of the textile batch were found within specifications. The visual examination of the 2 provided picture shows that during an open procedure. The textile knitting pattern seems to match with symbotex textile knitting pattern. However, the green flap is not visible, and the picture does not allow to detect if a collagen film was present and its state. Neither mesh failure nor adhesions to the mesh are visible. A piece of flat is visible on the mesh. However, we could not determine with the picture if this flat was protruding through the mesh. No fixation system is visible in the picture. Without the sample a detailed investigation could not be performed. The reported condition could not be confirmed. The reported information is too limited to determine the root cause or most probable cause of the reported incident and/or to determine if the incident is associated with a manufacturing or component discrepancy. It should be noted that the incident arrived ¿when they were getting to sew the patient up¿. Based on our investigation and a complaint history review, the manufacture of the device is not suspected. There is no indication that there is a defective lot or that this event represents an emerging adverse quality trend. Although a specific root cause analysis could not be performed, the incident is maintained in our database for a broader trend analysis. If additional information is obtained, or the sample is returned, we will re-open this investigation if information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during a ventral hernia procedure, the surgeon noted that the mesh was defective due to the fat was protruding through the mesh when it was sewn into the abdominal wall. Removed the reported mesh and replaced with a new a device. It was sutured and the skin was stapled back together. The surgical time was extended 45 minutes due to the product problem.

• Brand Name: SYMBOTEX
• 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: lisa hernandez ; 60 middletown ave.; north haven, CT 06473 ; 2034925563
• MDR Report Key: 8523296
• MDR Text Key: 142230250
• Report Number: 9615742-2019-01363
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131969
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial
• Report Date: 04/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: SYM8OS
• Device Catalogue Number: SYM8OS
• Device Lot Number: PRK1515X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/26/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/25/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 04/17/2019 Patient Sequence Number: 1