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 Adhesion(s) (1695); Foreign Body Reaction (1868); Inflammation (1932); Hernia (2240); Injury (2348); Fibrosis (3167); 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 an incisional.It was reported that after the implant, the patient experienced recurrence, foreign body reaction, adhesions, inflammation, benign adipose and fibrous tissue, giant diastasis, and mesh herniated into diastasis.Post-operative patient treatment included revision surgery and removal of mesh.

• 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: 9982882
• MDR Text Key: 188398223
• Report Number: 9615742-2020-00952
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10884521190450
• UDI-Public: 10884521190450
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2020
• Device Model Number: SYM2015
• Device Catalogue Number: SYM2015
• Device Lot Number: PPI0418X
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/08/2020
• Date Device Manufactured: 09/21/2015
• 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): Required Intervention