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

Model Number TECRT6

Device Problems Material Deformation (2976); Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Emotional Changes (1831); Fistula (1862); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Inflammation (1932); Muscle Weakness (1967); Nausea (1970); Pain (1994); Distress (2329); Depression (2361); Impaired Healing (2378); 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 bilateral inguinal hernia. It was reported that after the implant, the patient experienced chronic wound infection due to infected mesh, pain, disability, psychological stress, depression, loss of enjoyment of life, mesh contraction, mesh tented, attenuation, oozing site, discharging sinus tract, fistulous track, phlegmonous track, inflammation, bloody serious discharge, nausea, non-healing wound, loss of soft tissue, and mental anguish. Post-operative patient treatment included additional surgery, hospitalizations, antibiotics, wound packed, and removal of mesh.

• 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: 14116628
• MDR Text Key: 289315880
• Report Number: 9615742-2022-00326
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: NONE
• 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: 04/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 07/01/2014
• Device Model Number: TECRT6
• Device Catalogue Number: TECRT6
• Device Lot Number: SJH00166
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/16/2022
• Was Device Evaluated by Manufacturer?: No Answer Provided
• 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: 04/14/2022 Patient Sequence Number: 1