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

Model Number SYM2015

Device Problems Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abscess (1690); Adhesion(s) (1695); Purulent Discharge (1812); Fever (1858); Fistula (1862); Hematoma (1884); Unspecified Infection (1930); Pain (1994); Scar Tissue (2060); Discharge (2225); Hernia (2240); Injury (2348); Ascites (2596); Blood Loss (2597); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4). If information is provided in the future, a supplemental report will be issued.

Event Description

The patient¿s attorney alleged a deficiency against the device. The product was used for laparoscopic therapeutic treatment of a ventral hernia. It was reported that after implant, the patient experienced infected mesh, mesh was surrounded by brown liquid/abscess/stool, multi-lobulated fluids, hematoma, free air, fistula, fluid collection, pain, fever, gas pockets, bulging of the mesh, blood tinged fluid, purulent material, spillage of colon contents, scar tissue, omentum torn, recurrence, and adhesions. Post-operative patient treatment included revision surgery, lysis of omental adhesions to the mesh, drainage of abscess, numerous tacks removed, hernia repair with new mesh, left-sided tar release, pico dressing, and mesh removal.

• 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 ave; north haven, CT 06473 ; 2034925563
• MDR Report Key: 10740944
• MDR Text Key: 213216330
• Report Number: 9615742-2020-02398
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131969
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer

Reporter Occupation

• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 10/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 12/31/2020
• Device Model Number: SYM2015
• Device Catalogue Number: SYM2015
• Device Lot Number: PPL0794X
• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/07/2020
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 01/12/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 10/27/2020 Patient Sequence Number: 1

Treatment

UNKNOWN PROTACK (LOT#: UNKNOWN)