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

Model Number	PCO3020FX
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Adhesion(s) (1695); Fistula (1862); Unspecified Infection (1930); Pain (1994); Seroma (2069); Hernia (2240); Injury (2348)
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient's attorney alleged a deficiency against the device resulting in an unspecified adverse outcome.Product was used for therapeutic treatment.The patient underwent a laparoscopic ventral hernia and laparoscopic adhesiolysis.He had revision surgery 8 months post-surgery.The patient underwent a open repair recurrent ventral left lower quadrant hernia with mesh and open ventral hernia repair, primary right mid abdominal hernia.The patient underwent another revision surgery 2 years and 7 months.The patient underwent a exploratory laparotomy, extensive lysis of adhesions and resection of two enterocutaneous fistulae with creation of small bowel to small bowel anastomosis, excision of infected abdominal wall, incisional hernia repair and complex closure of the abdominal wall.The patient experienced pain, seroma, adhesions, infection, hernia recurrence and fistula.

• Brand Name: MESH SOFRADIM - PARIETEX¿ OPTIMIZED COMPOSITE MESH
• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): SOFRADIM PRODUCTION SAS; 116 avenue du formans; trevoux 01600 ; FR 01600
• MDR Report Key: 7129328
• Report Number: 9615742-2017-06164
• Device Sequence Number: 13775015
• Product Code: FTL
• UDI-Device Identifier: 10884521179844
• UDI-Public: 10884521179844
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K110663
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date (Section B): 12/19/2017

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: 04/30/2013
• Device Model Number: PCO3020FX
• Device Catalogue Number: PCO3020FX
• Device Lot Number: PLD00536
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2017
• Initial Report FDA Received Date: 12/19/2017
• 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: Other; Required Intervention