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

Model Number UNKNOWN MESH

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

Patient Problems Adhesion(s) (1695); Pain (1994); Hernia (2240); Anxiety (2328); 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 hernia.It was reported that after the implant, the patient experienced recurrence, adhesions, small bowel obstruction, pain, and mesh migration.Post-operative patient treatment included small bowel resection, mesh removal, multiple abdominal surgeries for mesh removal and incarcerated ventral abdominal wall hernia.

Event Description

The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of a hernia.It was reported that after the implant, the patient experienced recurrence, adhesions, small bowel obstruction, pain, anxiety, and mesh migration.Post-operative patient treatment included medication, small bowel resection, mesh removal, multiple abdominal surgeries for mesh removal and incarcerated ventral abdominal wall hernia, exploratory laparoscopy, extensive adhesiolysis, reduction of sb, ih, vih, sbo, repair of vih with suture, jp drains, hernia repair with new mesh.

Manufacturer Narrative

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.

• 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 ; 5920 longbow drive; 8200 coral sea st ne; mounds view,mn, CO 55112 ; 7635265677
• MDR Report Key: 15099945
• MDR Text Key: 296554908
• Report Number: 9615742-2022-00661
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 06/19/2024

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 Model Number: UNKNOWN MESH
• Device Catalogue Number: UNKNOWN MESH
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/20/2022
• Initial Date FDA Received: 07/25/2022
• Supplement Dates Manufacturer Received: 06/12/2024
• Supplement Dates FDA Received: 06/19/2024
• 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
• Patient Sex: Female
• Patient Weight: 98 KG