BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    ECONO STERILE¿

    MDR report key: 23371652 · Received October 23, 2025

    Report

    Report Number
    2431166-2025-00010
    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
    OK, 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 10/13/2025, A CUSTOMER NOTIFIED SKLAR THAT THREE INSTRUMENTS FROM A CASE OF 96-2549 ECONO STERILE¿ ROCHESTER-PEAN FORCEPS, CURVED, 8 1/2" CS/50 HAD A HOLE IN THE STERILE PACKAGING. THIS WAS NOTED ON INCOMING INSPECTION. THE DEVICES WERE NOT USED ON ANY PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2739231 ECONO STERILE¿ ECONO STERILE¿ ROCHESTER-PEAN FORCEPS, CURVED, 8 1/2" CS/50 GEN SKLAR INSTRUMENTS 96-2549 600033

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown