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

Model Number UNKNOWN PARIETEX

Device Problems Loss of or Failure to Bond (1068); Material Perforation (2205); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Fistula (1862); Unspecified Infection (1930); Necrosis (1971); Perforation (2001); Pneumothorax (2012); Discharge (2225); Hernia (2240); Injury (2348); Impaired Healing (2378); Respiratory Failure (2484); Abdominal Distention (2601); No Code Available (3191)

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 laparoscopic therapeutic treatment of a recurrent incisional hernia. It was reported that after implant, the patient experienced recurrence, large amount of adhesions of bowel to intra-abdominal wall, previous mesh partially incorporated, abundant serosanguineous drainage, respiratory failure, abdominal wound infection, fistula, and distal jejunal perforation with intra-abdominal soilage of intestinal contents. Post-operative patient treatment included recurrent incisional hernia repair with new mesh, mesh removed from grossly infected field and biliary contents from the peritoneal cavity suctioned free as well as debridement of wound, tracheostomy, removal of remnant mesh, and wound vac.

• 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: lisa hernandez ; 60 middletown ave; north haven, CT 06473 ; 2034925563
• MDR Report Key: 8508978
• MDR Text Key: 141757470
• Report Number: 9615742-2019-01252
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup,Followup
• Report Date: 10/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: UNKNOWN PARIETEX
• Device Catalogue Number: UNKNOWN PARIETEX
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/15/2019
• 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: 04/12/2019 Patient Sequence Number: 1