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

Model Number PCO9F

Device Problems Migration or Expulsion of Device (1395); Material Integrity Problem (2978); Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Abscess (1690); Adhesion(s) (1695); Emotional Changes (1831); Fistula (1862); Hematoma (1884); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Pain (1994); Perforation (2001); Scar Tissue (2060); Seroma (2069); Hernia (2240); Distress (2329); Depression (2361); Obstruction/Occlusion (2422); Unspecified Tissue Injury (4559)

Event Type  Injury  

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, pain, scarring, adhesions, infection, abscess, blood loss, intestinal blockage, fistula, hematoma, seroma, perforation, mental pain, disability, depression, psychological stress, loss of enjoyment of life, defective mesh, mesh contraction, and mesh migration. Post-operative patient treatment included revision surgery, mesh revision, removal of mesh, and hospitalization.

Manufacturer Narrative

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

• 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: 13906213
• MDR Text Key: 288024121
• Report Number: 9615742-2022-00259
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NONE
• 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: 03/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: PCO9F
• Device Catalogue Number: PCO9F
• Device Lot Number: PIJ00232
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/09/2022
• 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: 03/25/2022 Patient Sequence Number: 1