BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PARIETENE MESH PRODUCT

    MDR report key: 21252094 · Received January 28, 2025

    Report

    Report Number
    9615742-2025-00085
    Event Type
    Injury
    Date Received
    January 28, 2025
    Date of Event
    November 24, 2024
    Report Date
    January 30, 2025
    Manufacturer
    SOFRADIM PRODUCTION SAS
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT PRODUCT: UNK SURGIPRO MESH, UNKNOWN SURGIPRO MESH (LOT#UNKNOWN) IS MESH PORE SIZE ASSOCIATED WITH THE OUTCOME IN LAPARO-ENDOSCOPIC INGUINAL HERNIA REPAIR? ¿ A REGISTRY-BASED MULTIVARIABLE ANALYSIS. / F. KÖCKERLING, J. WREDE, D. ADOLF, D. JACOB2, H. RIEDIGER / HERNIA (2025) 29:47 / HTTPS://DOI.ORG/10.1007/S10029-024-03235-1 / PUBLISHED ONLINE: 13 DECEMBER 2024. 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. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    CORRECTION: H6 (IME, IMF) ADDITIONAL INFORMATION: G3 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 ANALYSIS OF DATA FROM THE HERNIAMED REGISTRY AIMED TO ANALYZE WHETHER MESH PORE SIZE WAS RELATED TO THE OUTCOME IN LAPARO-ENDOSCOPIC INGUINAL REPAIR. A TOTAL OF 83,768 CASES USING 21 DIFFERENT SURGICAL MESH TYPES WERE ANALYZED. OF THESE CASES, MEDTRONIC MESH (SURGIPRO, PARIETENE STANDARD, PARIETENE LIGHT, OR PARIETENE MACROPOROS) WERE USED IN 13,015 CASES. OVER THE ENTIRE COHORT COMPLICATIONS MENTIONED INCLUDED HERNIA RECURRENCE, CHRONIC PAIN REQUIRING TREATMENT, AND UNSPECIFIED POSTOPERATIVE COMPLICATIONS. INTERVENTIONS LISTED FOR THE COHORT INCLUDED COMPLICATION-RELATED REOPERATIONS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1501375 UNKNOWN PARIETENE MESH PRODUCT MESH, SURGICAL, POLYMERIC FTL SOFRADIM PRODUCTION SAS UNKNOWN PARIETENE MESH PRODUCT

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other| R PLEASE SEE NOTE ON H11