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

Model Number UNKNOWN SYMBOTEX MESH

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

Patient Problems Abdominal Pain (1685); Emotional Changes (1831); Pain (1994); Hernia (2240); Distress (2329); Discomfort (2330); Injury (2348); Disability (2371); Abdominal Distention (2601)

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 ventral hernia. It was reported that after implant, the patient experienced abdominal pain, bulging, bowel issues, recurrence, pain, suffering, emotional distress, disability, impairment, loss of enjoyment of life, loss of care, and loss of comfort. Post-operative patient treatment included excision of abdominal wall, mesh removal, and repair of abdominal wall using component separation technique and open component of the abdominal wall.

• Brand Name: SYMBOTEX MESH
• 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: 10774829
• MDR Text Key: 214314384
• Report Number: 9615742-2020-02459
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer

Reporter Occupation

• Type of Report: Initial
• Report Date: 11/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: UNKNOWN SYMBOTEX MESH
• Device Catalogue Number: UNKNOWN SYMBOTEX MESH
• 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: 10/14/2020
• Was Device Evaluated by Manufacturer?: No Answer Provided
• 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: 11/02/2020 Patient Sequence Number: 1