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 Hernia (2240); No Code Available (3191)

Event Date 02/14/2020

Event Type  Injury  

Manufacturer Narrative

Title: implantation of biologic mesh in ventral hernia repair - does it make sense? | source: abdelkader taibi1,2 · sophiane derbal1 · sylvaine durand fontanier1,2 | visceral surgery department, limoges university hospital, limoges, france | received: 8 august 2019 / accepted: 10 february 2020 | springer science+business media, llc, part of springer nature 2020 | https://doi.Org/10.1007/s00464-020-07435-5.(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

According to the literature, (february 2009-february 2015 ) this study aimed to evaluate the outcomes of implantation of biologic mesh in ventral hernia repair.68 patients with incisional hernia that were implanted with biological mesh, and it was reported that 42 had an issue of recurrence, and 7 required replacement of a new mesh.

• 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: 9910822
• MDR Text Key: 185941544
• Report Number: 9615742-2020-00764
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2020
• 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
• Date Manufacturer Received: 03/17/2020
• 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): Required Intervention
• Patient Age: 65 YR