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

Model Number	SYM2012EF
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Adhesion(s) (1695); Obstruction/Occlusion (2422); No Code Available (3191)
Date of Event	12/05/2019
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, post laparoscopic treatment of an umbilical hernia with intraperitoneal mesh inlay, it was noted that there was very pronounced adhesions of small intestine at the net with consecutive small intestine ileus (intestinal obstruction).The patient undergone emergency surgery.Which started laparoscopically but converted to open surgery due to unusual extent of adhesions.

• Brand Name: SYMBOTEX
• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): SOFRADIM PRODUCTION SAS; 116 avenue du formans; trevoux 01600 ; FR 01600
• MDR Report Key: 10494203
• Report Number: 9615742-2020-01924
• Device Sequence Number: 3274038
• Product Code: FTL
• UDI-Device Identifier: 10884521190443
• UDI-Public: 10884521190443
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K131969
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/04/2020

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: SYM2012EF
• Device Catalogue Number: SYM2012EF
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2020
• Initial Report FDA Received Date: 09/04/2020
• 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
• Patient Age: 49 YR