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

Model Number SYM3020

Device Problems Migration or Expulsion of Device (1395); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001); Material Split, Cut or Torn (4008)

Patient Problems Abscess (1690); Adhesion(s) (1695); Erosion (1750); Seroma (2069); Hernia (2240); Ascites (2596); Fluid Discharge (2686); Unspecified Tissue Injury (4559)

Event Type  Injury  

Manufacturer Narrative

Concomitant product: bard- mesh ventralex st sm circle, product id 595007, lot # hudr1683, unknown tacker (lot# unknown). 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 a laparoscopic therapeutic treatment of a incisional hernia and open epigastric incisional hernia. The patient¿s attorney alleged a deficiency against the device. It was reported that after implant, the patient experienced adhesions, mesh pulled away, omentum and bowel were protruding through prior mesh, drainage of seroma through abdominal wall, prior mesh appeared to be distorted/palpated, abscess, mesh erosion, fluid filled abdominal wall, peritoneal fluid, and recurrence. Post-operative patient treatment included lysis of adhesions, removal of mesh, hernia repair surgery with mesh, catheter placement, drainage surgery, bilateral transversus abdominis release, seroma drained, seroma fluid aspirated, and myofascial component separation.

• 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: tracy landers ; 5920 longbow drive; boulder, CO 80301 ; 3035816943
• MDR Report Key: 12029163
• MDR Text Key: 257264914
• Report Number: 9615742-2021-01538
• Device Sequence Number: 1
• Product Code: FTL
• 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

• Type of Report: Initial
• Report Date: 06/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: SYM3020
• Device Catalogue Number: SYM3020
• Device Lot Number: PRJ0850X
• 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: 06/02/2021
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 11/23/2017
• 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: 06/18/2021 Patient Sequence Number: 1