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

Model Number SYM9

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

Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Calcium Deposits/Calcification (1758); Foreign Body Reaction (1868); Granuloma (1876); Necrosis (1971); Nerve Damage (1979); Pain (1994); Scar Tissue (2060); Hernia (2240); Injury (2348); Foreign Body In Patient (2687); Fibrosis (3167); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Concomitant product: abstack30x abs fixation device30 tacks, (lot # n6h0363mx). (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 therapeutic treatment of a ventral hernia. It was reported that after the implant, the patient experienced fibroconnective soft tissue, degenerative changes, calcification, necrosis, foreign body reaction, fibrous tissue, abdominal pain, adhesions, foreign body material, scar tissue, granuloma, pain, meshoma, neuroma/neuralgia, palpable nodule, mesh rolled, diastasis, and histiocytic response. Post-operative patient treatment included revision surgery, diagnostic laparoscopy, biopsy of foreign material, removal of foreign body abdominal wall, removal of granuloma, neurectomy, excision of left inguinal nerves, meshoma removed, debridement, multiple hernia repairs, partial removal of mesh, and hernia repair with new 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: 10446084
• MDR Text Key: 204172415
• Report Number: 9615742-2020-01893
• 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
• Report Date: 08/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 02/28/2022
• Device Model Number: SYM9
• Device Catalogue Number: SYM9
• Device Lot Number: PRB2303X
• 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: 08/05/2020
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 03/02/2017
• 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: 08/24/2020 Patient Sequence Number: 1