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

Model Number TEC1515

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

Patient Problems Fistula (1862); Unspecified Infection (1930); Discharge (2225); Injury (2348); Impaired Healing (2378)

Event Type  Injury  

Manufacturer Narrative

Concomitant products: wl gore mycromesh plus 15 x 19 (lot # 13374847 and 15148973).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 incisional hernia.It was reported that after implant, the patient experienced chronic wound, sinus and wound infection, infected abdomen and wound with wound sinus, chronic draining sinus, chronic non-healing wound, infected mesh, unincorporated mesh, and fistula tract.Post-operative patient treatment included incision and drainage of chronic wound, application of wound vac, removal of several pieces of mesh material, debridement with removal of mesh, and excision of retained mesh with nonhealing wound exploration and debridement.The device had been used with concomitant devices wl gore mycromesh plus 15 x 19 (x2), lot #'s 13374847 and 15148973.

• 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: 8987447
• MDR Text Key: 158054116
• Report Number: 9615742-2019-03017
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10884521180260
• UDI-Public: 10884521180260
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K982532
• 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
• Report Date: 09/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2019
• Device Model Number: TEC1515
• Device Catalogue Number: TEC1515
• Device Lot Number: SOK0469X
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/14/2019
• Date Device Manufactured: 11/29/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention