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 Death (1802); Sepsis (2067); No Code Available (3191); Multiple Organ Failure (3261)

Event Date 05/20/2009

Event Type  Injury  

Manufacturer Narrative

(b)(4).Title: long-term results of laparoscopic repair of incisional hernias using an intraperitoneal composite mesh | alfredo moreno-egea æ jose´ antonio castillo bustos æ enrique girela æ jose´ luis aguayo-albasini | source: 27 january 2009 / accepted: 20 may 2009 / published online: 17 june 2009 springer science+business media, llc 2009.If information is provided in the future, a supplemental report will be issued.[(b)(4)].

Event Description

According to the literature, (january 1994 and december 2006), this study aimed to evaluate the long-term complications and recurrences of laparoscopic repair of incisional hernias.Data for 200 consecutive patients who underwent laparoscopic incisional hernia repair (lihr) in a university teaching hospital ere collected prospectively.The median follow-up was 6 (range, 1¿12) years.A double-layer mesh was used in all cases.One patient had an intestinal injury which diagnosed during the immediate postoperative period and reoperation was performed due to abdominal sepsis.During the operation an intestinal resection was performed and the patch was removed.The patient progressed to multiple organ failure and died as a result of a sepsis.

• 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: 8733254
• MDR Text Key: 149164048
• Report Number: 9615742-2019-02296
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2019
• 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
• Date Manufacturer Received: 06/04/2019
• 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): Required Intervention