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

Model Number UNKNOWN PARIETEX PROGRIP

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

Patient Problems Pain (1994); Hernia (2240); Post Operative Wound Infection (2446); No Code Available (3191)

Event Date 06/22/2019

Event Type  Injury  

Manufacturer Narrative

Title of article: laparoscopic totally extra-peritoneal groin hernia repair with self-gripping polyester mesh: a series of 780 repairs authors: bethany stavert, daniel l.Chan, john ozmen, and ken loi year: 2019.(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

According to the literature, the study conducted includes a retrospective case series.The study included 514 patients who underwent 780 laparoscopic inguinal hernia repairs.Post-operatively, it was reported that 4 hernia recurrences occurred and three of these subsequently underwent open redo-hernia repairs.Thirteen patients reported chronic pain and 1 patient experienced would infection.

• Brand Name: UNKNOWN PARIETEX PROGRIP
• 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: 9203438
• MDR Text Key: 162872672
• Report Number: 9615742-2019-03475
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 10/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN PARIETEX PROGRIP
• Device Catalogue Number: UNKNOWN PARIETEX PROGRIP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/30/2019
• 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
• Patient Age: 57 YR