BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PROGRIP MESH PRODUCT

    MDR report key: 19355360 · Received May 20, 2024

    Report

    Report Number
    9615742-2024-00709
    Event Type
    Injury
    Date Received
    May 20, 2024
    Report Date
    May 20, 2024
    Manufacturer
    SOFRADIM PRODUCTION SAS
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    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.

    Description of Event or Problem · 0

    ACCORDING TO THE REPORTER, TWO PIECES OF MESH WERE PUT BACK IN THE PATIENT IN (B)(6) 2019. IN (B)(6) 2021, 90% OF THE MESH WAS REMOVED. IT WAS NOTED THAT THE PATIENT HAS BEEN DEALING WITH SEVERE PAIN, AUTOIMMUNE, AND HEALTH ISSUES EVER SINCE AND IS NOW DISABLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1769033 UNKNOWN PROGRIP MESH PRODUCT MESH, SURGICAL, POLYMERIC FTL SOFRADIM PRODUCTION SAS UNKNOWN PROGRIP MESH PRODUCT

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| O