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

Model Number SYM2015

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Abdominal Pain (1685); Abscess (1690); Bacterial Infection (1735); Purulent Discharge (1812); Fever (1858); Unspecified Infection (1930); Necrosis (1971); Pneumonia (2011); Diaphoresis (2452); Ascites (2596); Fluid Discharge (2686); 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 laparoscopic therapeutic treatment of a ventral hernia.It was reported that after implant, the patient experienced infection, abscess, bacterial infection, free intraperitoneal air, abdominal pain, fever, sweats, fluid collection, purulent material, nonviable tissue, fibrinous material, yellowish discoloration in central aspect of wound, lack of incorporation, necrosis, exudative tissue, and pneumonia.Post-operative patient treatment included revision surgery, medication, admission to hospital, aspiration of anterior abdominal fluid collection, incision/drainage of abscess, placement of drain, debridement of wound, closure of fascia, hernia repair with new mesh, removal of tacks, subcutaneous tissue/fascial edges debrided of nonviable tissue, irrigation of abdominal wound, replacement of wound vac, removal of wound vac, closure of wound, picc line placed, and removal of 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: 11578384
• MDR Text Key: 242672614
• Report Number: 9615742-2021-00705
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10884521190450
• UDI-Public: 10884521190450
• 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: 03/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2020
• Device Model Number: SYM2015
• Device Catalogue Number: SYM2015
• Device Lot Number: PPL0794X
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/10/2021
• Initial Date FDA Received: 03/26/2021
• Date Device Manufactured: 01/12/2016
• 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): Hospitalization; Required Intervention
• Patient Weight: 115