BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROGRIP

    MDR report key: 22086244 · Received May 27, 2025

    Report

    Report Number
    9615742-2025-00566
    Event Type
    Injury
    Date Received
    May 27, 2025
    Date of Event
    March 14, 2025
    Report Date
    May 27, 2025
    Manufacturer
    SOFRADIM PRODUCTION SAS
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: G2 (REMOVED DISTRIBUTOR, ADD LITERATURE). 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

    GIUSEPPE DI BUONO. "PROGRIP VERSUS PROFLOR: TWO FXATION-FREE DEVICES FOR LAPAROSCOPIC INGUINAL HERNIA REPAIR¿THE PRO/PRO STUDY, A RANDOMIZED CLINICAL TRIAL", 2024, SURGICAL ENDOSCOPY (2025) 39:3113¿3126 HTTPS://DOI.ORG/10.1007/S00464-025-11680-X. 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 INCLUDING 132 CASES OF LAPAROSCOPIC TRANSABDOMINAL PREPERITONEAL HERNIA REPAIR WITH MESH FOR BILATERAL INGUINAL HERNIAS BETWEEN JANUARY 2021 TO JUNE 2022 WAS COMPLETED. ALL PATIENTS UNDERWENT THE TRANSABDOMINAL PREPERITONEAL SURGERY. A LAPAROSCOPIC SELF-FIXATING MESH WAS USED ON 65 PATIENTS AND A COMPETITOR MESH PRODUCT WAS USED ON 67 PATIENTS TO COVER THE HERNIA DEFECT. SEVEN PATIENTS WHO UNDERWENT THE SELF-FIXATING MESH EXPERIENCED CHRONIC PAIN. AMONG THE CASES, FIVE WERE RESOLVED WITHIN SIX MONTHS WITH MEDICAL TREATMENT, WHILE THE REMAINING TWO CASES CONTINUED TO REPORT PAIN BEYOND THE PERIOD OF THE INVESTIGATION. TWO PATIENTS OF A SELF-FIXATING MESH NOTICED ONE-SIDED RECURRENCE WITHIN 24 MONTH POST-SURGERY. THE RECURRENCE IN THE SELF-FIXATING MESH INVOLVED PATIENTS WITH HERNIA DEFECTS LARGER THAN 35MM. POST OPERATIVE COMPLICATIONS INCLUDE HERNIA RECURRENCE, PROLONGED PAIN, SEROMA AND HEMATOMA FORMATION OCCURRED IN 23 CASES. AN UNKNOWN MEDICAL INTERVENTION WAS NEEDED FOR PAIN RESOLUTION. NO INTERVENTIONS WERE MENTIONED FOR HERNIA RECURRENCE. PROGRIP VERSUS PROFLOR: TWO FIXATION-FREE DEVICES FOR LAPAROSCOPIC INGUINAL HERNIA REPAIR¿THE PRO/PRO STUDY, A RANDOMIZED CLINICAL TRIAL, GIUSEPPE DI BUONO, 2025, SURGICAL ENDOSCOPY

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1013540 PROGRIP MESH, SURGICAL, POLYMERIC FTL SOFRADIM PRODUCTION SAS UNKNOWN PROGRIP MESH PRODUCT

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Male Required Intervention