MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS UNKNOWN PARIETEX PRODUCT; MESH, SURGICAL, POLYMERIC

Model Number UNKNOWN PARIETEX PRODUCT

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

Patient Problems Pain (1994); Seroma (2069); Hernia (2240)

Event Date 04/01/2017

Event Type  Injury  

Manufacturer Narrative

Title massive incisional hernia repair with parietex: monocentric analysis on 500 cases treated with a laparoscopic approach source journal of laparoendoscopic <(>&<)> advanced surgical techniques, volume 27, 2017 (388-392) article number: 4.Information is provided in the future, a supplemental report will be issued.

Event Description

According to the literature case, laparoscopic incisional hernia repair was performed by applying a three-dimensional polyester knit structure mesh with a resorbable collagen barrier on peritoneal side.500 patients were divided into three groups according to the different fixation devices.Following the laparoscopic incisional hernia repair, seromas were observed in 20 patients, and neuralgia in 10 patients.Also, recurrence was observed in 12 patients with the majority in the absorbable tack group.

• Brand Name: UNKNOWN PARIETEX PRODUCT
• 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: lisa hernandez ; 60 middletown ave.; north haven, CT 06473 ; 2034925563
• MDR Report Key: 9530816
• MDR Text Key: 179621852
• Report Number: 9615742-2019-03919
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2019
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2019
• 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