Parietex
Received Jul 30, 2026
Report 9615742-2026-00725 · MDR key 50089215
Device
Generic name
Mesh, Surgical, Polymeric
Manufacturer
Sofradim Production SasModel number
UNKNOWN PARIETEXCatalog number
UNKNOWN PARIETEX
Product problems
- Adverse Event Without Identified Device or Use Problem
- Patient Device Interaction Problem
Patient
Female
- Adhesion(s)
- Fistula
- Unspecified Infection
- Pain
- Seroma
- Hernia
- Unspecified Gastrointestinal Problem
- Unspecified Tissue Injury
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
Narrative
Description of Event or Problem
The patient's attorney alleged a deficiency against the device. The product was used for therapeutic treatment of an umbilical hernia. It was reported that after implant, the patient experienced infection, seroma, recurrence, pain, adhesions, fistula, sinus tract, unincorporated mesh, and gastrointestinal problems. Post-operative patient treatment included removal of mesh, small bowel resection, abdominal wall debridement of infected seroma, hernia repair with new mesh and medication.
Additional 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.