MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS MESH TSL - PERMACOL; MESH, SURGICAL

Model Number UNKNOWN PERMACOL PRODUCT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Hernia (2240); No Code Available (3191)

Event Date 04/28/2020

Event Type  Injury  

Manufacturer Narrative

Title: outcome after pediatric liver transplantation for staged abdominal wall closure with use of biological mesh¿study with long-term follow-up source: pediatric transplantation.2020;24:e13683 https://doi.Org/10.1111/petr.13683.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the literature, (year january 2011 to december 2014) this study aimed to assess the outcome of a retrospective study compared the use of abdominal wall closure in pediatric liver transplantation with and without the use of biological mesh.There were 21 patients included in this study, 16 of which utilized biological mesh.Post-operative complications included late-onset abdominal wall infection on the 97th day post-op.During the observation period over 5 years, 2 additional patients developed abdominal wall hernias, one of which required surgical intervention.An additional patient required re-transplantation for chronic allograft failure after 21 months.

• Brand Name: MESH TSL - PERMACOL
• Type of Device: MESH, SURGICAL
• 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: 10809623
• MDR Text Key: 215303179
• Report Number: 9615742-2020-02475
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN PERMACOL PRODUCT
• Device Catalogue Number: UNKNOWN PERMACOL PRODUCT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/26/2020
• Initial Date FDA Received: 11/09/2020
• 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
• Patient Outcome(s): Other; Required Intervention