BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VELOSORB FAST

    MDR report key: 14780775 · Received June 22, 2022

    Report

    Report Number
    3006981798-2022-00020
    Event Type
    Injury
    Date Received
    June 22, 2022
    Date of Event
    March 4, 2022
    Report Date
    June 22, 2022
    Manufacturer
    RIVERPOINT MEDICAL LLC
    Product Code
    GAM
    UDI-DI
    20884521152257
    PMA / PMN Number
    K120556
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT WAS RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND ALL PRODUCT MET REQUIREMENTS PRIOR TO RELEASE. PRODUCT RETAINS FROM THE SAME LOT OF PRODUCT WERE TESTED FOR FINISHED GOODS TESTING, WHICH INCLUDED TENSILE STRENGTH AND MOISTURE TESTING, ALL SAMPLES PASSED. THE REPORT COULD NOT BE SUBSTANTIATED AND 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 BY 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, "FOLLOWING A LAPAROSCOPIC SEPTOPLASTY AND FUNCTIONAL ENDOSCOPIC SINUS SURGERY WHERE THE DEVICE WAS USED FOR SKIN CLOSURE, TISSUE DAMAGE WAS NOTED. THERE WAS A POSSIBLE DEHISCENCE AND THERE WAS A GRANULOMAS FORMING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256608 VELOSORB FAST BRAIDED FAST ABSORBABLE SUTURE GAM RIVERPOINT MEDICAL LLC SV-2920 21062114 20884521152257

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown