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

Model Number PCO15X

Device Problems Material Integrity Problem (2978); Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Emotional Changes (1831); Fever (1858); Hematoma (1884); Unspecified Infection (1930); Pain (1994); Scar Tissue (2060); Seroma (2069); Hernia (2240); Distress (2329); Obstruction/Occlusion (2422); Ascites (2596); Unspecified Tissue Injury (4559)

Event Type  Injury  

Manufacturer Narrative

Concomitant devices: bard- mesh surg marlex 6x6in groin hernia patch knitted flat sheet sterile polyprop, product id 0117011, lot # eme844. 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 a ventral incisional hernia. It was reported that after underlay the implant, the patient experienced infection, seroma, chronic hematomas, fluid collection, adhesions, hernia recurrence, abdominal pain, fever, chronic pain and suffering. Post-operative patient treatment included revision surgeries, hematoma drained and excised, incision and drainage of fluid collection, and hernia repair with 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: 12066816
• MDR Text Key: 258367811
• Report Number: 9615742-2021-01555
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110815
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 04/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 11/30/2014
• Device Model Number: PCO15X
• Device Catalogue Number: PCO15X
• Device Lot Number: PML00233
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/23/2022
• 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: 06/25/2021 Patient Sequence Number: 1