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

Model Number	SYM12F
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abdominal Pain (1685); Unspecified Infection (1930); No Code Available (3191)
Date of Event	03/06/2017
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, during scar herniotomy, an intraperitoneal onlay mesh (ipom) was implanted on the patient.A second surgery was performed but it was due to adhesions so the mesh were left inside.The patient then had chronic abdominal scar pain, infection of the ipom and light-graded secretion at the umbilicus.The mesh was explanted by median laparotomy and the patient was prescribed with needs-based analgesia.There was no florid signs of inflammation in the material which was sent in.It was a pronounced foreign body reaction.The patient was hospitalized for four days.

• 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: 8325120
• Report Number: 9615742-2019-00284
• Device Sequence Number: 1774752
• Product Code: FTL
• UDI-Device Identifier: 10884521190351
• UDI-Public: 10884521190351
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/11/2019

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: 10/31/2020
• Device Model Number: SYM12F
• Device Catalogue Number: SYM12F
• Device Lot Number: PPJ0752X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2019
• Initial Report FDA Received Date: 02/11/2019
• 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: Hospitalization; Required Intervention
• Patient Age: 22 YR