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

Model Number SYM2015OS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Tissue Damage (2104)

Event Date 02/02/2018

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during an open ventral hernia repair procedure, while being applied for intraperitoneal onlay mesh - ipom, the device was used, however patient incurred tissue damage, wherein small bowel was meshed.In order to resolve the issue, specimen was collected for microscopic examination.Surgical intervention such as the resection of small bowel meshed and temporary ileostomy were done in order to prevent a permanent impairment of a function.As a result, there was prolonged surgery due to removal of the mesh.Patient was alive.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: SYMBOTEX
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): SOFRADIM PRODUCTION SAS; 116 avenue du formans; trevoux 01600 ; FR 01600
• Manufacturer (Section G): SOFRADIM PRODUCTION SAS; 116 avenue du formans; trevoux 01600 ; FR 01600
• Manufacturer Contact: lisa hernandez ; 60 middletown avenue; north haven, CT 06473 ; 2034925563
• MDR Report Key: 7310816
• MDR Text Key: 101419031
• Report Number: 9615742-2018-00411
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10884521190467
• UDI-Public: 10884521190467
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K131969
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 08/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2021
• Device Model Number: SYM2015OS
• Device Catalogue Number: SYM2015OS
• Device Lot Number: PQL0184X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/13/2018
• Date Device Manufactured: 12/24/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 57 YR