BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERMACOL

    MDR report key: 24015133 · Received January 8, 2026

    Report

    Report Number
    9615742-2026-00010
    Event Type
    Injury
    Date Received
    January 8, 2026
    Date of Event
    April 30, 2024
    Report Date
    January 8, 2026
    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

    CARLOTTA LA RAJA, ANNALISA MAROLI, CATERINA FOPPA, ROBERTO GABBIADINI , ARIANNA DAL BUONO, ALESSANDRO ARMUZZI, MICHELE CARVELLO, ANTONINO SPINELLI, COLLAGEN PASTE INJECTION IN CROHN'S DISEASE PERIANAL FISTULA: LONG-TERM OUTCOMES OF A PILOT, PROSPECTIVE COHORT STUDY , JOURNAL OF THE ANUS, RECTUM AND COLON, 2024, VOLUME 8, ISSUE 4, PAGES 271-278, RELEASED ON J-STAGE OCTOBER 25, 2024, ONLINE ISSN 2432-3853, HTTPS://DOI.ORG/10.23922/JARC.2024-008, HTTPS://WWW.JSTAGE.JS T.GO.JP/ARTICLE/JARC/8/4/8_2024-008/_ARTICLE/-CHAR/EN 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 PROSPECTIVE STUDY AIMED TO ASSESS THE LONG-TERM EFFICACY OF COLLAGEN PASTE APPLICATION IN PATIENTS WITH SIMPLE AND COMPLEX CROHN¿S PERIANAL FISTULAS BETWEEN JANUARY 2019 AND SEPTEMBER 2021. AFTER CURETTAGE OF THE FISTULA TRACT, A COLLAGEN PASTE WAS INJECTED IN THE FISTULA TRACT TO FILL IT COMPLETELY AND THE OPENINGS WERE CLOSED WITH SUTURES. THERE WERE 14 PATIENTS IN THE STUDY. THREE PATIENTS DEVELOPED POSTOPERATIVE ABSCESSES AND CLINICAL RECURRENCE OCCURRED IN 5 PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64903 PERMACOL MESH, SURGICAL, POLYMERIC FTL SOFRADIM PRODUCTION SAS 6000-300

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other