MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS MESH SOFRADIM - PARIETEX COMPOSITE MESH MESH, SURGICAL, POLYMERIC

Model Number PCO3020

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

Patient Problems Purulent Discharge (1812); Erythema (1840); Granuloma (1876); Unspecified Infection (1930); Inflammation (1932); Scar Tissue (2060); Seroma (2069); Impaired Healing (2378); Ascites (2596); Fluid Discharge (2686); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

The patient¿s attorney alleged a deficiency against the device. The product was used for therapeutic treatment of an abdominal hernia. It was reported that after the onlay implant, the patient experienced infection, pus, fluid around mesh, chronic draining wounds, seroma, suture granuloma, scar tissue, induration, erythema, inflammation, cord lipoma, and draining sinus tract. Post-operative patient treatment included myofascial advancement of flap (component separation), revision surgery, incision/ debridement of wound, induration/ erythema excised, wounds packed, hernia repair with new mesh, removal of mesh/ tacks, and medication.

• Brand Name: MESH SOFRADIM - PARIETEX COMPOSITE MESH
• 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: 11683624
• MDR Text Key: 245972856
• Report Number: 9615742-2021-00851
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (Y/N): N
• Reporter Country Code: US
• PMA/PMN Number: K040998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: CONSUMER

Reporter Occupation

• Type of Report: Initial
• Report Date: 04/18/2021

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 04/18/2021
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device EXPIRATION Date: 04/30/2010
• Device MODEL Number: PCO3020
• Device Catalogue Number: PCO3020
• Device LOT Number: PFC00461
• Was Device Available For Evaluation?: No

Is The Reporter A Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/31/2021
• Was Device Evaluated By Manufacturer?: No Answer Provided
• Date Device Manufactured: 04/30/2005
• Is The Device Single Use?: Yes
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient TREATMENT DATA

Date Received: 04/18/2021 Patient Sequence Number: 1