BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VELOSORB FAST

    MDR report key: 17563898 · Received August 17, 2023

    Report

    Report Number
    3006981798-2023-00046
    Event Type
    Injury
    Date Received
    August 17, 2023
    Date of Event
    July 12, 2023
    Report Date
    August 17, 2023
    Manufacturer
    RIVERPOINT MEDICAL LLC
    Product Code
    GAM
    UDI-DI
    20884521151656
    PMA / PMN Number
    K120556
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS NOT BEEN RETURNED. PRODUCTION RECORDS WERE REVIEWED. THERE WERE NO NONCONFORMITIES NOTED WITH THE LOT DURING PRODUCTION. ALL FINISHED GOODS TESTING REQUIREMENTS WERE MET PRIOR TO RELEASE. THREE RETAINED SAMPLES FROM THE SAME LOT WERE USED TO PERFORM A NEEDLE ATTACHMENT TEST. THE RETAINED SAMPLES USED FOR THE NEEDLE ATTACHMENT TEST MET REQUIREMENTS. 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 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, "ACCORDING TO THE REPORTER, DURING A PERINEAL REPAIR, FOR THE PATIENT HAVING JUST GIVEN BIRTH, WHILE SUTURING, THE NEEDLE BECAME LODGED IN THE PATIENT'S SKIN AS THE THREAD CAME AWAY COMPLETELY. IT WAS EMBEDDED IN THE PERINEAL MUSCLE/TISSUE. THE SUTURE WAS VERY DIFFICULT TO REMOVE AND THIS WAS RECTIFIED BY REMOVING THE NEEDLE WITH SMALL FORCEPS, CAUSING ADDED DISCOMFORT TO THE AND REQUIRED FURTHER TISSUE INJURY TO THE PATIENT. THERE WAS BLOOD LOSS THAT DID NOT EXCEED 500 ML, SURGICAL TIME WAS EXTENDED BY 20 MINUTES, AND INCISION WAS EXTENDED SLIGHTLY. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1246319 VELOSORB FAST BRAIDED FAST ABSORBABLE SURGICAL SUTURE GAM RIVERPOINT MEDICAL LLC CV-917 22072814X 20884521151656

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention