MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS UNKNOWN PARIETEX PRODUCT

Model Number UNKNOWN PARIETEX PRODUCT

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

Patient Problems Necrosis (1971); Seroma (2069); Hernia (2240); Post Operative Wound Infection (2446)

Event Date 04/12/2020

Event Type  Injury  

Manufacturer Narrative

Title: case¿control comparison of separation of component retrorectus urinary bladder extracellular surgical device hernia repair with acellular dermal matrix underlay and prosthetic mesh overlay hernia repair.Source: international journal of abdominal wall and hernia surgery 2021;4:13-9.Published: 22-02-2021.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the literature source of study performed between may 1, 2012 and may 31, 2019, outcomes of patients who underwent two types of incisional hernia repairs were compared.One technique was the sandwich biologic mesh underlay/synthetic mesh overlay (buso) repair technique; the second technique was separation of components with retrorectus mesh (socrm).There were 28 patients in each group and complications included: superficial skin necrosis, superficial wound infection, hernia recurrence and seroma.Re-operation was required for hernia recurrence.Superficial surgical site infection and necrosis required antibiotics, bedside debridement or drainage of the infection.Seroma was treated with aspiration.Three patients required either ¿home health¿ assistance or placement at a skilled nursing.

• Brand Name: UNKNOWN PARIETEX PRODUCT
• 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: 12229281
• MDR Text Key: 263575026
• Report Number: 9615742-2021-01813
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2021
• 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: 07/06/2021
• 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