BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    ECONO STERILE¿

    MDR report key: 23372232 · Received October 23, 2025

    Report

    Report Number
    2431166-2025-00011
    Event Type
    Malfunction
    Date Received
    October 23, 2025
    Date of Event
    October 13, 2025
    Report Date
    October 23, 2025
    Manufacturer
    SKLAR INSTRUMENTS
    Product Code
    GEN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE NOT USED ON ANY PATIENT. PROBLEM NOTICED DURING INCOMING INSPECTION.

    Description of Event or Problem · 0

    ON (B)(6) 2025 A CUSTOMER NOTIFIED SKLAR OF A HOLE IN THE STERILE PACKAGING FOR 1 UNIT OF ECONO STERILE¿ PRESBYTERIAN TUBE OCCLUDING FORCEPS - 7", DISPOSABLE, CS/50. THIS WAS NOTED ON INCOMING INSPECTION. THE DEVICE WAS NOT USED ON ANY PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1931600 ECONO STERILE¿ PRESBYTERIAN TUBE OCCLUDING FORCEPS - 7", DISPOSABLE, CS 50 GEN SKLAR INSTRUMENTS 96-2406 600016

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown