BEUDAMED
    FDA Adverse Event Death Summary report: N

    PARIETEX

    MDR report key: 23182133 · Received September 30, 2025

    Report

    Report Number
    9615742-2025-01140
    Event Type
    Death
    Date Received
    September 30, 2025
    Report Date
    March 9, 2026
    Manufacturer
    SOFRADIM PRODUCTION SAS
    Product Code
    FTL
    UDI-DI
    10884521514164
    PMA / PMN Number
    K142908
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFO: A2 (DATE OF BIRTH), A3A, B2 (ADDED HOSPITALIZATION), B5, B7, D4 (MODEL #, CATALOG #, EXPIRATION DATE, LOT #, UDI #), G4 (510K #), H4, H6 (PATIENT CODES, IMF 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.

    Description of Event or Problem · 0

    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 IMPLANT, THE PATIENT EXPERIENCED EMOTIONAL DISTRESS, DEATH. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY. INFORMATION RECEIVED INDICATES THE PATIENT IS DECEASED. NO INFORMATION WAS PROVIDED REGARDING THE CIRCUMSTANCES OF EXPIRATION.

    Description of Event or Problem · 0

    THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF A VENTRAL INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ABDOMINAL PAIN, ABSCESS, ADHESIONS, OBSTRUCTION, RECURRENCE, FISTULA, INFECTION, PAIN, SUFFERING, EMOTIONAL DISTRESS, DEATH. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, BOWEL REMOVAL WITH PRIMARY ANASTOMOSIS, HOSPITALIZATIONS, NG TUBE PLACEMENT, MESH REVISION AND HERNIA REPAIR WITH NEW MESH. INFORMATION RECEIVED INDICATES THE PATIENT IS DECEASED. NO INFORMATION WAS PROVIDED REGARDING THE CIRCUMSTANCES OF EXPIRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114039 PARIETEX MESH, SURGICAL, POLYMERIC FTL SOFRADIM PRODUCTION SAS PCO8VP PVL0490X 10884521514164

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Hospitalization| D| R