BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PARIETEX PRODUCT

    MDR report key: 23726263 · Received December 5, 2025

    Report

    Report Number
    9615742-2025-01351
    Event Type
    Injury
    Date Received
    December 5, 2025
    Date of Event
    September 5, 2025
    Report Date
    December 5, 2025
    Manufacturer
    SOFRADIM PRODUCTION SAS
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT PRODUCTS: UNKNOWN PROGRIP, UNKNOWN PROGRIP MESH PRODUCT (LOT#: UNKNOWN) PARMAR, A.D. "ROBOTIC REPAIR OF OFF-MIDLINE ABDOMINAL WALL HERNIAS: A SINGLE INSTITUTION CONSECUTIVE CASE SERIES". HERNIA (2025) 29:283. HTTPS://DOI.ORG/10.1007/S10029-025-03476-8. 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

    ACCORDING TO THE LITERATURE, A RETROSPECTIVE STUDY COMPARED THE OUTCOMES OF PATIENTS WHO UNDERWENT ROBOTIC-ASSISTED REPAIR OF OFF MIDLINE ABDOMINAL WALL HERNIAS BETWEEN JUNE 2019 AND OCTOBER 2024. IT WAS NOTED THAT THE CHOICE OF MESH UTILIZED FOR REPAIR INCLUDED PROGRIP, PARIETEX OR A COMPETITOR PRODUCT. THERE WERE 43 PATIENTS INCLUDED IN THE STUDY AND COMPLICATIONS INCLUDED SURGICAL SITE ABSCESS, REOCCURRENCE, AND PERSISTENT PAIN LASTING > 3 MONTHS. INTERVENTIONS AND PATIENT OUTCOMES WERE UNKNOWN. ADDITIONALLY, TWO PATIENTS SUFFERED NERVE INJURY AND WERE TREATED WITH CRYOABLATION. DUTTA, P., KIM, G., ENGLISH, N., KATTA, T., NAIK, G., MUSTIAN, M., COREY, B., PARMAR, A.D. ROBOTIC REPAIR OF OFF-MIDLINE ABDOMINAL WALL HERNIAS: A SINGLE INSTITUTION CONSECUTIVE CASE SERIES. HERNIA (2025) 29:283. HTTPS://DOI.ORG/10.1007/S10029-025-03476-8.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2866339 UNKNOWN PARIETEX PRODUCT MESH, SURGICAL, POLYMERIC FTL SOFRADIM PRODUCTION SAS UNKNOWN PARIETEX PRODUCT

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female Required Intervention SEE H11.