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

Model Number TEM3015G

Device Problem Torn Material (3024)

Patient Problem No Code Available (3191)

Event Date 12/01/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4). If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter: post-operatively, the patient came back after one and half years after the surgery of ventral hernia in sublay technique because there was a recurrence of mesh ripped/torn. A surgical intervention was needed another surgery was necessary to repair his abdominal wall, he extended his stay in the hospital for 3 to 4 days more. The original mesh was not removed. The fascia was closed again and another mesh was placed on top and fixed with sutures. There will be an additional operation performed to correct the issue. The appearance of the mesh was white; dry, polyester + polylactide.

Event Description

According to the reporter, approximately a year and a half post-op, after a ventral hernia repair procedure, there was a recurrence of torn mesh. Another surgery was needed to repair the abdominal wall. Patient was discharged from the hospital after 4 days. The appearance of the mesh was white; dry, polyester and polylactid. The patient status is alive with a temporary injury.

• 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: 6761005
• MDR Text Key: 109544092
• Report Number: 9615742-2017-05196
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 07/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 09/30/2020
• Device Model Number: TEM3015G
• Device Catalogue Number: TEM3015G
• Device Lot Number: SPJ0231X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/31/2017
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 10/28/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 08/02/2017 Patient Sequence Number: 1