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 Hematoma (1884); Post Operative Wound Infection (2446)

Event Date 02/19/2021

Event Type  Injury  

Manufacturer Narrative

Title: outcome of open inguinal hernia repair using sutureless self-gripping mesh ¿ a retrospective single cohort study.Source: swiss medical weekly.2021;151:w20455.(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

According to literature source, a study was performed between 1st of october 2010 and 31st of january 2021 on 162 patients who underwent open inguinal hernia repair using sutureless self-gripping mesh (157 had unilateral inguinal hernia and 5 had bilateral hernia).Reported complications were hernia recurrence (5 patients), hematoma (2 patients), and surgical site infection.Reoperations for 6 patients were required for recurrence and hematoma.The infection was treated with antibiotics.

• 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: tracy landers ; 5920 longbow drive; boulder, CO 80301 ; 3035816943
• MDR Report Key: 12591809
• MDR Text Key: 275223669
• Report Number: 9615742-2021-02264
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: 10/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2021
• 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: 09/22/2021
• 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): Required Intervention