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	Inflammation (1932); Pain (1994); Radiation Exposure, Unintended (3164); No Code Available (3191)
Date of Event	07/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Evaluation summary: one device was returned for investigation.A review of the device history record has been performed and no failure that may relate to the reported conditions have been noted.The visual examination of the 8 provided pictures shows: pictures 1 & 2 show a well-integrated mesh in vivo with a similar knitting pattern than sym meshes.However it is not possible to determine the mesh dimension.The mkr textile is not visible on the picture.A suture yarn seems to be incorporated between the mesh and the abdominal wall on the picture 1.A ¿hole¿ seems to be visible in the middle of the mesh on the picture 1 (3ds textile not visible) but due to the quality of the picture we could not assure that.Picture 3 to 8 seems to show the inflammation.The reported condition seems to be confirmed.The reported information is too limited to determine the root cause or most probable cause of the reported incident and/or to determine if the incident is associated with a manufacturing or component discrepancy.The reported pain and inflammation are known potential complications of this type of surgery; this is a procedural related complication that is not normally attributed to any product/process deficiencies.Based on the available information, our investigation and a complaint history review, the manufacture of the device is not suspected.There is no indication that there is a defective lot or that this event represents an emerging adverse quality trend.The known complication of the procedure.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, post-operative from laparoscopic intraperitoneal onlay mesh (ipom) for umbilical hernia, directly after t he surgery, the patient always complained of pain, which was explained by the surgeon as due to the fixation.However, even after the year the pain did not disappear and only increased so the patient went to the emergency department and stayed in the hospital for 4 1/2 weeks.Ct was made and inflammation between abdominal wall and mesh was detected.Repeat laparoscopy was performed.Duodenitis and gastritis were also detected.The event led to inflammation and pain.The condition improved after antibiotics but there was still pain in mesh area.

• 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: 8511595
• Report Number: 9615742-2019-01269
• Device Sequence Number: 1471346
• 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): 04/12/2019

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: 09/30/2021
• Device Model Number: SYM12F
• Device Catalogue Number: SYM12F
• Device Lot Number: PQI1279X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2019
• Initial Report FDA Received Date: 04/12/2019
• 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: 55 YR
• Patient Weight: 102