BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHROMIC GUT

    MDR report key: 23118090 · Received September 22, 2025

    Report

    Report Number
    3006981798-2025-00038
    Event Type
    Malfunction
    Date Received
    September 22, 2025
    Date of Event
    August 26, 2025
    Report Date
    September 22, 2025
    Manufacturer
    RIVERPOINT MEDICAL LLC
    Product Code
    GAL
    PMA / PMN Number
    K001299
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    RETURN SAMPLES WERE TESTED FOR TENSILE STRENGTH VIA THE KNOT PULL METHOD. LOT 250401607 RETURN SAMPLES EXCEEDED THE USP AVERAGE STANDARD FOR CHROMIC GUT SIZE 4-0 BY APPROXIMATELY 44%. REVIEW OF THE DHR FOR LOT 250401607 CONFIRMED THAT THE LOT MET ALL TENSILE STRENGTH REQUIREMENTS PRIOR TO RELEASE. LOT 250401607 SAMPLES EXCEEDED THE USP AVERAGE STANDARD FOR CHROMIC GUT SIZE 4-0 BY APPROXIMATELY 64%. THE POUCH SEAL STRENGTH AND WIDTH ALSO MET ALL SPECIFICATIONS. THREE RETAIN SAMPLES FROM THE LOT WERE ALSO TESTED FOR TENSILE STRENGTH. THE RETAIN SAMPLES EXCEEDED THE USP AVERAGE STANDARD FOR CHROMIC GUT SIZE 4-0 BY APPROXIMATELY 36%. THERE WERE NO NONCONFORMITIES NOTED WITH THE LOT DURING PRODUCTION. THERE WERE NO NONCONFORMITIES WITH THE RAW MATERIAL USED. ALL FINISHED GOODS TESTING REQUIREMENTS WERE MET PRIOR TO RELEASE. THERE WAS NO EVIDENCE THAT THE DEVICE FAILED TO MEET SPECIFICATIONS AND THE REPORT COULD NOT SUBSTANTIATED. A CAUSE FOR THE EVENT CANNOT BE ESTABLISHED. THIS REPORT AND USE OF CATEGORICAL DEFINITIONS REQUIRED BY FDA 3500A DOES NOT CONSTITUTE AN ADMISSION BY RIVERPOINT MEDICAL OR ITS EMPLOYEES THAT RIVERPOINT MEDICAL OR ITS EMPLOYEES HAS CAUSE OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. RIVERPOINT MEDICAL FILED THIS INFORMATION TO COMPLY WITH THE MEDICAL DEVICE REPORTING REGULATION 21 CFR 803. IF ADDITIONAL INFORMATION IS PROVIDED TO RIVERPOINT MEDICAL REGARDING THIS EVENT, A SUPPLEMENTARY 3500A FORM WILL BE SUBMITTED AS REQUIRED BY FDA. FILE ATTACHMENTS.

    Description of Event or Problem · 0

    ACCORDING TO THE REPORTER, "PER CUSTOMER EVERY TIME THEY USE IT IN OS THEY BEND AND IT BREAKS. I CALLED THE CUSTOMER TO VERIFY THAT THE ISSUE IS THE SUTURE IS BREAKING. THE NEEDLE IS OKAY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196512 CHROMIC GUT CHROMIC GUT NATURAL MONOFILAMENT SUTURE GAL RIVERPOINT MEDICAL LLC CG558 250401607

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown