MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS MESH SOFRADIM - PARIETEX¿ PROGRIP¿; MESH, SURGICAL, POLYMERIC

Model Number TEM1208GR

Device Problem Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/09/2017

Event Type  malfunction  

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter: procedure: open right inguinal hernia repair.The mesh out of the package showed no imperfections.The mesh tore during preparation prior to implant.The doctor trimmed the peripheral aspects of the mesh so it would cover the area he desired.He passed the suture through the mesh and then he took one bite through the tissue overlying the pubic tubercle and then passed the needle end of the suture through the mesh just medial to the blue stitch on the mesh.The surgeon then tied the suture knots to secure the mesh.It was at that time the mesh tore and the suture released from the mesh due to the strands of mesh tearing.The surgeon indicated that he included several of the strands of the mesh when he started the knot tying but the mesh tore and the suture released from the mesh.The surgeon opened another piece of the mesh and successfully implanted it without further incident.This reported issue was detected in the operating room after opening the package.The mesh appearance was normal.The tamper-evident seal on the box was not peeled or damaged.To complete the case, another was opened and used.There was no injury to the patient.The surgical time was not extended.

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

The visual examination of the sample shows that the sample was placed in a biohazard bag.The mesh was contaminated by blood.The shape of the mesh was modified by some cut around the mesh and the mesh was torn just under the blue yarn marker (less than 2 stitches).The reported condition was confirmed.Excessive manipulation by the user is highly suspected.A review of the device history records has been performed.This review confirmed that this lot of products was reviewed and released according to qa specification.If information is provided in the future, a supplemental report will be issued.

• Brand Name: MESH SOFRADIM - PARIETEX¿ PROGRIP¿
• 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: 6689558
• MDR Text Key: 79647637
• Report Number: 9615742-2017-05179
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10884521177697
• UDI-Public: 10884521177697
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K081050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Model Number: TEM1208GR
• Device Catalogue Number: TEM1208GR
• Device Lot Number: SQJ1017X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/16/2016
• 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 Weight: 70