BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROSUTURE

    MDR report key: 20305622 · Received September 25, 2024

    Report

    Report Number
    3006981798-2024-00045
    Event Type
    Malfunction
    Date Received
    September 25, 2024
    Date of Event
    August 27, 2024
    Report Date
    September 25, 2024
    Manufacturer
    RIVERPOINT MEDICAL LLC
    Product Code
    GAR
    UDI-DI
    00812444029017
    PMA / PMN Number
    K100006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT WAS RETURNED FOR EVALUATION. PRODUCTION RECORDS WERE REVIEWED. ONLY THE BACK BOX LABEL WAS AFFECTED, ALL OTHER LABELS CORRECTLY IDENTIFIED THE PRODUCT. THERE WERE NO NONCONFORMITIES NOTED WITH THE LOT DURING PRODUCTION. ALL FINISHED GOODS TESTING REQUIREMENTS WERE MET PRIOR TO RELEASE. 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 HAVE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THIS REPORT. RIVERPOINT MEDICAL HAS 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 THE FDA.

    Description of Event or Problem · 0

    ACCORDING TO THE REPORTER: "RECEIVED A PRODUCT COMPLAINT REGARDING A BOX OF GEM MICROSUTURE. THERE ARE TWO LABELS ON A BOX THAT DON'T MATCH IN REGARDS TO THE PRODUCT CODE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1243186 MICROSUTURE NYLON BLACK MONOFILAMENT SUTURE, GAR RIVERPOINT MEDICAL LLC GEM180BKC 23110618 00812444029017

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown