BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FH TAPE

    MDR report key: 21952813 · Received May 2, 2025

    Report

    Report Number
    3006981798-2025-00022
    Event Type
    Malfunction
    Date Received
    May 2, 2025
    Date of Event
    April 22, 2025
    Report Date
    May 1, 2025
    Manufacturer
    RIVERPOINT MEDICAL LLC
    Product Code
    GAT
    UDI-DI
    00840277405944
    PMA / PMN Number
    K153307
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS DISCARDED AND WILL NOT BE RETURNED. THE DHR AND POST-PRODUCTION RECORDS WERE REVIEWED AND THERE WERE NO ISSUES NOTED WITH THE LOT DURING PRODUCTION. ALL POST-PRODUCTION QUANTITIES WERE RECONCILED AND WERE CORRECT. 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, "THERE ARE 2 FH TAPE SUTURE IN THE BOX " (QTY 1 BOX)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1310176 FH TAPE BLUE/BLACK UHMWPE POLYBLEND BRAIDED NON-ABSORBABLE SUTURE GAT RIVERPOINT MEDICAL LLC HS524 24042413 00840277405944

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown