MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS MESH SOFRADIM - PARIETEX¿ OPTIMIZED COMPOSITE MESH MESH, SURGICAL, POLYMERIC

Model Number PCO6VP

Device Problem Degraded (1153)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/07/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the reporter, during an umbilical hernia repair procedure, while inserting the mesh, it was brittle and the strap broke. A new device was used to complete the case. No injury.

Manufacturer Narrative

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

Manufacturer Narrative

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 molding of the ring and the handles positioning were found within specifications. The visual examination of the returned sample shows that: the sample was returned in its original packaging (aluminum pouch, tray petg and tyvek lid). The commercial box was not provided. The sample was found contaminated by blood. The mesh dimension, sewing and the removable handles were found as expected. The collagen film was partially detached from the mesh, mainly around the mesh. The expanders were broken at 2 points: 1. A break at the quarter of the junction, on the side of the white handle 2. A break at half of the junction on the side of the blue handle the reported condition was confirmed. User error the mesh was broken in 2 sides of the pgla expanders, not in the normal location for folding the mesh. The product instructions for use (ifu) which accompanies each device states in chapter ¿operating steps ¿ positioning¿ that ¿3. Fold the hydrated parietex¿ composite ventral patch in half along the junction of the two violet expanders. ¿ a search of our global complaints database revealed that this was the only report on file for this lot of product. The review of historical data (complaint records from 25 january 2013 (initial ce-mark) to 30 november 2018) indicates that 5 cases (b)(4) coded as -mesh degradation- were reported. The report has been added to our product complaints database which is monitored for similar occurrences. 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. No immediate action required. The root cause is user error. If information is provided in the future, a supplemental report will be issued.

• Brand Name: MESH SOFRADIM - PARIETEX¿ OPTIMIZED COMPOSITE MESH
• 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: 8119709
• MDR Text Key: 128893145
• Report Number: 9615742-2018-02632
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120506
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 02/14/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 11/30/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: PCO6VP
• Device Catalogue Number: PCO6VP
• Device Lot Number: PSF0891X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2018
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/21/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/21/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial