BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 24364648 · Received February 17, 2026

    Report

    Report Number
    2210968-2026-01673
    Event Type
    Injury
    Date Received
    February 17, 2026
    Date of Event
    January 5, 2025
    Report Date
    February 17, 2026
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. AS NO CONTACT INFORMATION HAS BEEN PROVIDED, NO FOLLOW UP CAN OR WILL BE PERFORMED AT THIS TIME. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. CITATION: DOI: NOT PROVIDED

    Description of Event or Problem · 0

    TITLE: PROSPECTIVE, RANDOMIZED, BICENTRIC COMPARATIVE STUDY: BOVINE PERICARDIUM ALDEHYDE-FREE VERSUS NATIVE TISSUE IN THE TREATMENT OF PELVIC ORGAN PROLAPSE THE AIM OF THIS STUDY IS TO COMPARE THE EFFICACY AND SAFETY OF BOVINE PERICARDIUM GRAFTS TREATED WITH L-HYDRO ALDEHYDE-FREE TECHNOLOGY (BP) VERSUS TRADITIONAL NATIVE TISSUE (NT) FIXATION TO THE SACROSPINOUS LIGAMENT (SSL) IN THE TREATMENT OF HIGH-GRADE APICAL PELVIC ORGAN PROLAPSE (POP). BETWEEN MARCH TO OCTOBER 2024, A TOTAL OF 22 PATIENTS HAVE UNDERGONE SURGERY USING VICRYL 0 SUTURES. REPORTED COMPLICATIONS ARE: N=?; GLUTEAL AND PERINEAL PAIN TREATMENT: NOT MENTIONED N=1; TREATMENT FAILURE TREATMENT: REOPERATED FOR POP (PELVIC ORGAN PROLAPSE) IN CONCLUSION, HYSTEROPEXY USING BP GRAFTS TREATED WITH L-HYDRO ALDEHYDE-FREE TECHNOLOGY DEMONSTRATES PERIOPERATIVE EFFICACY AND SAFETY, WITH NO FAILURES OR ADVERSE EFFECTS REPORTED IN THE SHORT-TERM FOLLOW-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242076 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention