MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS UNKNOWN PARIETEX PRODUCT

Model Number UNKNOWN PARIETEX PRODUCT

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

Patient Problems Unspecified Infection (1930); Seroma (2069)

Event Date 07/14/2020

Event Type  Injury  

Manufacturer Narrative

Title: total endoscopic-assisted linea alba reconstruction (teslar) for treatment of umbilical/paraumbilical hernia and rectus abdominus diastasis is associated with unacceptable persistent seroma formation: a single centre experience source: hernia (2020) 24:1379¿1385 https://doi.Org/10.1007/s10029-020-02266-8 received: 20 may 2020 / accepted: 14 july 2020 / published online: 20 july 2020 © springer-verlag france sas, part of springer nature 2020.If information is provided in the future, a supplemental report will be issued.

Event Description

According to literature source of study performed between march 2018 and may 2019, total endoscopic-assisted linea alba reconstruction was performed to 21 patients and parietex was used to 3 patients.The aim of the study was to establish the risks and benefits of safely performing total endoscopic-assisted linea alba reconstruction.One patient suffered from severe postoperative infected collection following the procedure which required formal washout and removal of the mesh.Other postoperative complications include: seroma, chronic pain, and recurrence.Patients with seromas underwent aspirations and reoperation.

• Brand Name: UNKNOWN PARIETEX PRODUCT
• 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: tracy landers ; 5920 longbow drive; boulder, CO 80301 ; 3035816943
• MDR Report Key: 11891751
• MDR Text Key: 252885436
• Report Number: 9615742-2021-01392
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/26/2021

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 PARIETEX PRODUCT
• Device Catalogue Number: UNKNOWN PARIETEX PRODUCT
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/04/2021
• Initial Date FDA Received: 05/27/2021
• 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): Hospitalization; Required Intervention