BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDLINE

    MDR report key: 23789887 · Received December 12, 2025

    Report

    Report Number
    1417592-2025-00711
    Event Type
    Malfunction
    Date Received
    December 12, 2025
    Date of Event
    November 12, 2025
    Report Date
    January 19, 2026
    Manufacturer
    MEDLINE INDUSTRIES, LP
    Product Code
    FZS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATE TO H6. AFTER FURTHER INVESTIGATION, IT HAS BEEN DETERMINED THAT THE INVESTIGATOIN INVOLVED TESTING OF THE ACTUAL/SUSPECTED DEVICE, ANALYSIS OF PRODUCTION RECORDS, AND TREND ANALYSIS. THE INVESTIGATION FOUND NO DEVICE PROBLEM AND THE CAUSE WAS TRACED USER PERCEPTION AS THE REASON FOR THE REPORTED REDUCED SHARPNESS. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE PROVIDER WAS UNABLE TO COMPLETE DEBRIDEMENT DUE TO THE INEFFECTIVENESS/DULLNESS OF THE CURETTE IN REMOVING TISSUE. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT COULD CAUSE OR CONTRIBUTE TO SERIOUS INJURY IF IT WERE TO OCCUR. IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PROVIDER WAS UNABLE TO COMPLETE DEBRIDEMENT DUE TO THE INEFFECTIVENESS/DULLNESS OF THE CURETTE IN REMOVING TISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2761750 MEDLINE CURETTE, DERM, TRIANGLE HDL, DISP, 5MM FZS MEDLINE INDUSTRIES, LP 67424100008

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female Other