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

Model Number PCO2520FX

Device Problems Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Adhesion(s) (1695); Emotional Changes (1831); Pain (1994); Scar Tissue (2060); Hernia (2240); Deformity/ Disfigurement (2360); Unspecified Tissue Injury (4559)

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 ventral hernia.It was reported that after implant, the patient experienced recurrence, adhesions, pain, bowel complications, loss of enjoyment of life, disability, loss of mental health, scarring, disfigurement, defective mesh, mesh failure.Post-operative patient treatment included revision surgery, mesh revision.

• Brand Name: PARIETEX
• 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: 14049022
• MDR Text Key: 288859898
• Report Number: 9615742-2022-00291
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10884521179813
• UDI-Public: 10884521179813
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110663
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2019
• Device Model Number: PCO2520FX
• Device Catalogue Number: PCO2520FX
• Device Lot Number: POC0887X
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/23/2022
• 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; Disability