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

Model Number PPM4530

Device Problems Material Deformation (2976); Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Bacterial Infection (1735); Emotional Changes (1831); Foreign Body Reaction (1868); Unspecified Infection (1930); Inflammation (1932); Laceration(s) (1946); Pain (1994); Scar Tissue (2060); Hernia (2240); Discomfort (2330); 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 a ventral hernia. It was reported that after implant, the patient experienced mesh exposed at open wound, chronic open wound, infected mesh, scar tissue, sinus tract, adhesions, staphylococcus aureus, laceration, inflammation, biofilm formed on mesh, and abdominal wall pain. Post-operative patient treatment included lysis of adhesions, ct scan, debridement of wound/laceration, scar tissue removed, sinus tract removed, removal of mesh, inflamed tissue including umbilicus excised, tissue debridement, hernia repair with new mesh, diagnostic laparoscopy, removal of tacks, and two clips removed from subcutaneous tissue.

• 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: tracy landers ; 5920 longbow drive; boulder,co, CT 80301 ; 3035816943
• MDR Report Key: 11349312
• MDR Text Key: 232575724
• Report Number: 9615742-2021-00387
• Device Sequence Number: 1
• Product Code: FTL
• 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

• Type of Report: Initial,Followup
• Report Date: 03/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 08/31/2019
• Device Model Number: PPM4530
• Device Catalogue Number: PPM4530
• Device Lot Number: SOH0261X
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/09/2022
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 09/10/2014
• 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: 02/19/2021 Patient Sequence Number: 1