MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS PARIETENE; MESH, SURGICAL, POLYMERIC

Model Number PPM3030

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

Patient Problems Purulent Discharge (1812); Granuloma (1876); Failure of Implant (1924); Unspecified Infection (1930); Hernia (2240); Injury (2348); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 incisional hernia.It was reported that after the implant, the patient experienced recurrence, infection, sinus tract, purulent material, granuloma, and mesh failure.Post-operative patient treatment included revision surgery, excisional debridement of surgical site infection, removal of sutures, wound debridement, wound vac/dressings, and removal of mesh.

• Brand Name: PARIETENE
• 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: 9974150
• MDR Text Key: 188092161
• Report Number: 9615742-2020-00920
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10884521213784
• UDI-Public: 10884521213784
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142091
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/17/2020

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 Expiration Date: 06/30/2022
• Device Model Number: PPM3030
• Device Catalogue Number: PPM3030
• Device Lot Number: PPM3030
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/25/2020
• Initial Date FDA Received: 04/17/2020
• 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