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

Model Number PCO2520OS

Device Problems Material Erosion (1214); Migration or Expulsion of Device (1395); Product Quality Problem (1506); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Adhesion(s) (1695); Erosion (1750); Laceration(s) (1946); Pain (1994); Perforation (2001); Scar Tissue (2060); Scarring (2061); Cramp(s) (2193); Discharge (2225); Hernia (2240); Discomfort (2330); Injury (2348); Obstruction/Occlusion (2422); Fluid Discharge (2686); Cramp(s) /Muscle Spasm(s) (4521); 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 an incarcerated incisional hernia. It was reported that after implant, the patient experienced recurrence of an incisional hernia that was incarcerated and painful, erosion, adhesions, loops of small bowel adherent to the mesh, and wrinkled mesh causing bowel obstruction. Treatment for these conditions included surgical revision of the mesh, lysis of adhesions, resection of loops of small bowel adherent to mesh, hernia repair with sutures, and later explant of the mesh.

• Brand Name: MESH SOFRADIM - PARIETEX¿ COMPOSITE MESH
• 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: justin ellis ; 8200 coral sea st ne; mounds view,mn, CO 55112 ; 7635265677
• MDR Report Key: 8440181
• MDR Text Key: 139450556
• Report Number: 9615742-2019-00542
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050187
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 09/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 07/31/2014
• Device Model Number: PCO2520OS
• Device Catalogue Number: PCO2520OS
• Device Lot Number: PJH00031
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/07/2022
• 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: 03/21/2019 Patient Sequence Number: 1