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

Model Number SYM12

Device Problems Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Adhesion(s) (1695); Emotional Changes (1831); Pain (1994); Distress (2329); Obstruction/Occlusion (2422); Unspecified Tissue Injury (4559)

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 defective mesh, mental pain, disability, emotional distress, pain, obstruction, adhesions, loss of enjoyment of life, impairment.Post-operative patient treatment included lysis of adhesions.

Event Description

The patient's attorney alleged a deficiency against the device.The product was used for a laparoscopic therapeutic treatment of a ventral hernia.It was reported that after implant, the patient experienced defective mesh, mental pain, disability, emotional distress, pain, obstruction, adhesions, loss of enjoyment of life, impairment, ascites, discomfort, stabbing abdominal pain, colicky, & foreign body granuloma.Post-operative patient treatment included lysis of adhesions, ct scan, lap enterolysis, biopsies, debridement, & partial removal of tackers.

Manufacturer Narrative

D10 (product id - reltack4xdpt, lot number - n5d0779ux), medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• 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: 14189373
• MDR Text Key: 289901175
• Report Number: 9615742-2022-00367
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10884521190344
• UDI-Public: 10884521190344
• 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: 04/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SYM12
• Device Catalogue Number: SYM12
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/06/2022
• 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
• Treatment: SEE H11 COMMENT
• Patient Outcome(s): Disability; Required Intervention
• Patient Sex: Female
• Patient Weight: 56 KG
• Patient Race: White