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

Model Number	TEC2020
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fistula (1862); Unspecified Infection (1930); Discharge (2225); Injury (2348); Impaired Healing (2378)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: wl gore mycromesh plus 15x19 (lot# 13374847 and 15148973).If information is provided in the future, a supplemental report will be issued.
Event or Problem 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 15x19 (x2), lot#'s 13374847 and 15148973.

• Brand Name: PARIETEX
• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): SOFRADIM PRODUCTION SAS; 116 avenue du formans; trevoux 01600 ; FR 01600
• MDR Report Key: 8987441
• Report Number: 9615742-2019-03016
• Device Sequence Number: 14271547
• Product Code: FTL
• UDI-Device Identifier: 10884521180277
• UDI-Public: 10884521180277
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K982532
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/01/2019
• Device Model Number: TEC2020
• Device Catalogue Number: TEC2020
• Device Lot Number: SOC0853X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2019
• Initial Report FDA Received Date: 09/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention