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 Wound Dehiscence (1154); Bacterial Infection (1735); Hernia (2240)

Event Date 07/28/2020

Event Type  Injury  

Manufacturer Narrative

Title: s116: impact of incisional negative pressure wound therapy on surgical site infection after complex incisional hernia repair: a retrospective matched cohort study source: surgical endoscopy (2021) 35:3949¿3960.If information is provided in the future, a supplemental report will be issued.

Event Description

According to literature source of study performed between january 2016 and december 2019, there were 114 patients who underwent complex incisional hernia repair were divided into two groups depending on dressing type: incisional negative pressure wound therapy (inpwt) or standard sterile dressings (ssd). complications included surgical site infection, enterocutaneous (ec) fistula were experienced by two(2) patients, wound dehiscence for eighteen(18) patients, seroma for twenty eight(28) patients.Wound interventions includes: antibiotic therapy for twenty three (23) patients, interventional radiology (ir) drainage for twelve (12) patients, wound opened for fourteen (14) patients and reoperation for five(5) patients. a total of twenty two (22) patients had a thirty (30) day readmission as well.Hernia recurrence was also reported for seven(7) patients.

• 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
• MDR Report Key: 12741570
• MDR Text Key: 279794153
• Report Number: 9615742-2021-02393
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial
• Report Date: 11/02/2021

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: 10/14/2021
• Initial Date FDA Received: 11/02/2021
• 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