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
• UDI-Device Identifier: 10884521180062
• UDI-Public: 10884521180062
• 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

1 Patient was 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
• Date Manufacturer Received: 09/29/2020
• 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
• Patient Sequence Number: 1