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

Model Number	PCO2H4
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Tissue Damage (2104); Vomiting (2144); Perforation of Esophagus (2399); No Code Available (3191)
Date of Event	04/17/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, four years after a nissen fundoplication on hiatal hernia, the patient returned at the hospital throwing up and with pain.The patient's esophagus was perforated which required an exploratory laparotomy, intestinal resection, and removal of the mesh.The surgical time was extended by 30 minutes or more due to the product problem, an extended incision by more than 1 inch or 2.54cm and tissue damage.The event also lead to extended patient hospitalization.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: MESH SOFRADIM - PARIETEX¿ 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: 7699573
• Report Number: 9615742-2018-01610
• Device Sequence Number: 1041126
• Product Code: FTL
• UDI-Device Identifier: 10884521178472
• UDI-Public: 10884521178472
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K040998
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2018

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 Model Number: PCO2H4
• Device Catalogue Number: PCO2H4
• Device Lot Number: PMI00648
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/03/2018
• Supplement Date Received by Manufacturer: 08/08/2018
• Initial Report FDA Received Date: 07/18/2018
• Supplement Report FDA Received Date: 10/03/2018
• 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: Hospitalization; Required Intervention