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

Model Number TEM1208GL

Device Problem Torn Material (3024)

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

Event Date 04/03/2017

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: during an open inguinal hernia procedure, using the lichtenstein method, the mesh was torn while the surgeon applied it around the spermatic cord.There was no injury as a result of the event.To correct the condition the surgeon used another mesh.The current patient status is alive with no injury.

Manufacturer Narrative

Evaluation summary: post market vigilance led an evaluation of one device.The visual examination of the returned sample shows that the sample was not returned in its original packaging: only the commercial box and the ifu.A review of the device history record has been performed.This review confirmed that this lot of products was reviewed and released according to qa specifications.Especially the review of qc records related to the mechanical testing of the textile batches used for this lot confirms compliance to qa specifications.The mesh was placed in a plastic pouch.The mesh was not contaminated by blood.The dimensions of the mesh were found as expected.The mesh was found torn from the central pre-cut hole until 1 cm opposite edge of the flap.This type of damage would be consistent with high force being applied when opening the flap.The mesh seems to have been tear by the user.The mesh seems to have been cut by the user below the colored yarn marker.Excessive manipulation by the user is highly suspected.The root cause could not be determined.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter: per additional information received the surgeon was preparing it with forceps before implanting when it tore.The mesh looked as usual, there was no problem noticed.

• 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 avenue; north haven, CT 06473 ; 2034925267
• MDR Report Key: 6538371
• MDR Text Key: 74305641
• Report Number: 9615742-2017-05119
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10884521177680
• UDI-Public: 10884521177680
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K081050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2022
• Device Model Number: TEM1208GL
• Device Catalogue Number: TEM1208GL
• Device Lot Number: SRA2494X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/08/2017
• 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