BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VELOSORB FAST

    MDR report key: 12910284 · Received December 1, 2021

    Report

    Report Number
    3006981798-2021-00029
    Event Type
    Injury
    Date Received
    December 1, 2021
    Date of Event
    August 27, 2021
    Report Date
    December 1, 2021
    Manufacturer
    RIVERPOINT MEDICAL LLC
    Product Code
    GAM
    UDI-DI
    20884521153285
    PMA / PMN Number
    K120556
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DHR FOR THE LOT WAS PERFORMED AND NO ISSUES WERE NOTED DURING MANUFACTURING AND NO ISSUES WERE NOTED DURING MANUFACTURING AND ALL FINISHED GOODS TESTING REQUIREMENTS WERE MET PRIOR TO LOT RELEASE. RETAIN SAMPLES FROM THE SAME LOT WERE TESTED FOR FINISHED GOODS TESTING, INCLUDING SUTURE TENSILE STRENGTH AND NEEDLE ATTACHMENT TESTING. TEST RESULTS SHOW THAT ALL RETAIN SAMPLES PASSED. INVESTIGATIONS PERFORMED DID NOT REVEAL ANY ISSUES WITH THE PRODUCT AND THE REPORT COULD NOT BE SUBSTANTIATED. 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 PART 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, "DURING A PROCEDURE, THE NEEDLE DETACHED FROM THE THREAD AND SITUATED ITSELF WITHIN THE PATIENT SKIN, A SMALL INCISION WAS NEEDED TO REMOVE THE NEEDLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1807577 VELOSORB FAST SUTURE GAM RIVERPOINT MEDICAL LLC SV9915 20062313 20884521153285

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention