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

Model Number SYM9

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

Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Emotional Changes (1831); Unspecified Infection (1930); Inflammation (1932); Nerve Damage (1979); Pain (1994); Scar Tissue (2060); Hernia (2240); Ascites (2596); Abdominal Distention (2601); Fluid Discharge (2686); Unspecified Tissue Injury (4559)

Event Type  Injury  

Event Description

The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of incisional hernia.It was reported that after implant, the patient experienced recurrence, mesh failure, pain, adhesions, bulging, abdominal wall fluid collection, inflammation, infection, scarring, nerve damage, defective device, mental pain, suffering, disability, permanent impairment, and loss of enjoyment of life.Post-operative patient treatment included revision surgery.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: a4, b7 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.

Manufacturer Narrative

Additional info: a1, a2, a3a, b5, b6, b7, g1, h6 (patient codes).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.

Event Description

The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of incisional hernia.It was reported that after implant, the patient experienced recurrence, mesh failure, pain, adhesions, bulging, abdominal wall fluid collection, inflammation, infection, scarring, nerve damage, defective device, mental pain, suffering, disability, permanent impairment, loss of enjoyment of life, serosanguinous fluid, abdominal pain, oozing.Post-operative patient treatment included revision surgery, hernia repair with mesh, incisional hernia repair, ct scan, ct guided aspiration of fluid collection, pain medication, component separation, diagnostic lap, lysis of adhesions.

• 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: justin ellis ; 8200 coral sea st ne; mounds view,mn, CO 55112 ; 7635265677
• MDR Report Key: 14519776
• MDR Text Key: 292792074
• Report Number: 9615742-2022-00485
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10884521190634
• UDI-Public: 10884521190634
• 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,Followup,Followup
• Report Date: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SYM9
• Device Catalogue Number: SYM9
• Device Lot Number: PUD0302X
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/20/2024
• Date Device Manufactured: 04/09/2020
• 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): Required Intervention; Disability
• Patient Sex: Male
• Patient Weight: 127 KG