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

Model Number SYM9

Device Problems Migration or Expulsion of Device (1395); Product Quality Problem (1506); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Adhesion(s) (1695); Hernia (2240); Injury (2348); No Code Available (3191)

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 laparoscopic therapeutic treatment of a ventral hernia. It was reported that after implant, the patient experienced recurrence, significant intra-abdominal adhesions, previous mesh that was placed for the ventral hernia previously was parachuting up into the defect so the entire mesh was ballooning up into the defect, and bilateral component separation with bilateral musculocutaneous advancement flaps. Post-operative patient treatment included recurrent incisional ventral hernia repair with new mesh as well as the mesh was intimately involved with the skin so it would need to have surgical excision of the skin in order to free the mesh. Exploratory laparotomy, complex closure of 20 cm, and explant of previous mesh were also performed.

• 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: 8492800
• MDR Text Key: 141240569
• Report Number: 9615742-2019-01095
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 08/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 12/31/2019
• Device Model Number: SYM9
• Device Catalogue Number: SYM9
• Device Lot Number: POL0772X
• 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: 05/15/2019
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 01/07/2015
• 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: 04/08/2019 Patient Sequence Number: 1