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

Model Number SYM2520

Device Problems Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Adhesion(s) (1695); Hernia (2240); Fibrosis (3167); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

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 therapeutic treatment of a hernia.It was reported that after implant, the patient experienced mesh design defect, adhesions, fibrinous tissue, large diastasis with loss of domain, and hernia recurrence.Post-operative patient treatment included hernia repair with mesh, lysis of adhesions, removal of mesh, fibrinous tissue excised, bilateral myocutaneous flap creation, bilateral component separation, and a revision surgery.

• 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: 11794924
• MDR Text Key: 249661318
• Report Number: 9615742-2021-01029
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10884521190481
• UDI-Public: 10884521190481
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142908
• 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: 05/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2022
• Device Model Number: SYM2520
• Device Catalogue Number: SYM2520
• Device Lot Number: PRC1111X
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/21/2021
• Date Device Manufactured: 04/06/2017
• 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