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

Model Number PCO1510OSX

Device Problems Material Erosion (1214); Migration or Expulsion of Device (1395); Material Perforation (2205); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Abscess (1690); Adhesion(s) (1695); Erosion (1750); Unspecified Infection (1930); Internal Organ Perforation (1987); Pain (1994); Perforation (2001); Scar Tissue (2060); Scarring (2061); Seroma (2069); Hernia (2240); Injury (2348); Obstruction/Occlusion (2422); Fluid Discharge (2686); Nodule (4551); 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 a hernia. It was reported that after implant, the patient experienced small bowel adhered to mesh, hernia recurrence, small bowel perforation, fluid discharge, abscess, small bowel eroded into the anterior wall mesh, and large mass of small bowel scarring. Treatment provided for these conditions include lysis of adhesions, surgical revision with new mesh, irrigation and drainage, small bowel resection, and transgastric jejunostomy tube was placed.

Event Description

The patient¿s attorney alleged a deficiency against the device. The product was used for therapeutic treatment of an incisional hernia. It was reported that after implant, the patient experienced small bowel adhered to mesh, lateral aspect of mesh pulled away, hernia recurrence, small bowel perforation, fluid discharge, abscess, small bowel eroded into the anterior wall mesh, infection, obstruction, pain, seroma, and large mass of small bowel scarring. Treatment provided for these conditions include lysis of adhesions, surgical revision with new mesh, irrigation and drainage, small bowel resection, transgastric jejunostomy tube was placed, extended hospital stay, icu, and suture repair of small bowel perforation.

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, CT 80301 ; 3035816943
• MDR Report Key: 8131974
• MDR Text Key: 129295138
• Report Number: 9615742-2018-02679
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110816
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 07/31/2018
• Device Model Number: PCO1510OSX
• Device Catalogue Number: PCO1510OSX
• Device Lot Number: PNH0264X
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/17/2021
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 08/25/2013
• 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: 12/05/2018 Patient Sequence Number: 1