BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUTURELOOP HI-FI SUTURE

    MDR report key: 23686947 · Received December 1, 2025

    Report

    Report Number
    3006981798-2025-00049
    Event Type
    Malfunction
    Date Received
    December 1, 2025
    Date of Event
    October 20, 2025
    Report Date
    December 1, 2025
    Manufacturer
    RIVERPOINT MEDICAL LLC
    Product Code
    GAT
    UDI-DI
    00810020085846
    PMA / PMN Number
    K252201
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DHR AND POST-PRODUCTION RECORDS WERE REVIEWED AND THERE WERE NO ISSUES NOTED WITH THE LOT DURING PRODUCTION. THERE WAS NO EVIDENCE THAT THE DEVICE FAILED TO MEET SPECIFICATIONS, AND THE REPORT COULD NOT BE 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 EMPLOYEEES 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.

    Description of Event or Problem · 0

    ACCORDING TO THE REPORTER: "RECEIVED INCORRECT SUTURE IN BOX NO INTERACTION WITH PATIENT, CUSTOMER NOTICED UPON OPENING BOX".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2814136 SUTURELOOP HI-FI SUTURE WHITE/BLUE UHMWPE POLYBLEND BRAIDED NON-ABSORBABLE WHIP STITCH SUTURE GAT RIVERPOINT MEDICAL LLC HL200 25051516 00810020085846

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown