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

Model Number TECR1410DP2

Device Problems Loss of or Failure to Bond (1068); Product Quality Problem (1506)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/24/2020

Event Type  Malfunction  

Manufacturer Narrative

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

Event Description

According to the reporter, on a laparoscopic totally extraperitoneal inguinal hernia repair, after the insertion to the patient during mesh deployment and placement, there appeared to be a knot in the thread. When the surgeon went to pull the thread out of the mesh to position it inside the patient, the thread kept gathering and pulling the mesh. There was a knot which the surgeon had to cut to remove the thread and deploy the mesh. The thread then came out in 2 separate pieces. Extra time of about 15 minutes was added to the procedure due to the issue. There was no patient injury.

• Brand Name: PARIETEX
• 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: 10707865
• MDR Text Key: 212256011
• Report Number: 9615742-2020-02371
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (Y/N): N
• Reporter Country Code: NZ
• PMA/PMN Number: K982532
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: COMPANY REPRESENTATIVE,FOREIG
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Type of Report: Initial
• Report Date: 10/20/2020

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 10/20/2020
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device MODEL Number: TECR1410DP2
• Device Catalogue Number: TECR1410DP2
• Device LOT Number: SUC0867M
• 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: 09/29/2020
• Was Device Evaluated By Manufacturer?: No Answer Provided
• Date Device Manufactured: 03/19/2020
• Is The Device Single Use?: Yes
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial