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

Model Number	TCM1515X3
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Injury (2348); No Code Available (3191)
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.Preoperative ­­­­­­­­­­­­­­­­­­­and postoperative diagnosis was left inguinal hernia and left inguinal skin tag.The procedure performed was laparoscopic repair of incarcerated ventral hernia with 15-cm round mesh placed in the preperitoneal location.The patient underwent a second surgical procedure of a laparoscopic davinci-assisted repair of very large left inguinal hernia, incarcerated and excision of left inguinal skin tag.Pre-operative and post-operative diagnosis was left inguinal hernia and left inguinal skin tag.The patient also has had a surgical revision and recurrence.

• 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: 6916849
• Report Number: 9615742-2017-05404
• Device Sequence Number: 13573976
• Product Code: FTL
• UDI-Device Identifier: 10884521178885
• UDI-Public: 10884521178885
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K090858
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date (Section B): 09/13/2017

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: 12/31/2020
• Device Model Number: TCM1515X3
• Device Catalogue Number: TCM1515X3
• Device Lot Number: SQA0112X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2017
• Initial Report FDA Received Date: 10/05/2017
• 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