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

Model Number PCO3020

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Abdominal Pain (1685); Abscess (1690); Adhesion(s) (1695); Purulent Discharge (1812); Fistula (1862); Unspecified Infection (1930); Inflammation (1932); Ischemia (1942); Necrosis (1971); Perforation (2001); Renal Failure (2041); Scarring (2061); Sepsis (2067); Ulceration (2116); Jaundice (2187); Hernia (2240); Discomfort (2330); Injury (2348); Impaired Healing (2378); Blood Loss (2597); Abdominal Distention (2601); Bowel Perforation (2668); Fibrosis (3167); No Code Available (3191)

Event Type  Death  

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 recurrent incisional hernia. It was reported that after implant, the patient experienced fistula, abscess, adhesions of bowel to mesh, infected mesh, recurrence and necrosis. Post-operative patient treatment included wound vac, small bowel resection and revision surgery. The patient is deceased and no information was provided regarding the circumstances of expiration or any association with this device.

• 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: lisa hernandez ; 60 middletown ave; north haven, CT 06473 ; 2034925563
• MDR Report Key: 9653654
• MDR Text Key: 177177873
• Report Number: 9615742-2020-00306
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer

Reporter Occupation

• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 03/30/2013
• Device Model Number: PCO3020
• Device Catalogue Number: PCO3020
• Device Lot Number: PID00141
• 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: 09/15/2020
• 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: 01/31/2020 Patient Sequence Number: 1