BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    ECONO STERILE¿

    MDR report key: 22331215 · Received June 25, 2025

    Report

    Report Number
    2431166-2025-00006
    Event Type
    Malfunction
    Date Received
    June 25, 2025
    Date of Event
    June 23, 2025
    Report Date
    June 25, 2025
    Manufacturer
    SKLAR INSTRUMENTS
    Product Code
    GEN
    UDI-DI
    10649111059513
    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

    THERE WAS A HOLE FOUND IN ONE STERILE POUCH FROM A CASE OF 50 STERILE KELLY FORCEPS, PRODUCT NUMBER 96-2562, COMPROMISING THE STERILITY. THE ISSUE WAS CAUGHT FOR THE PRODUCT IN QUESTION DURING INCOMING INSPECTION. THE PRODUCT WAS NOT USED ON ANY PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1327591 ECONO STERILE¿ KELLY FORCEPS CURVED 5 1/2" CS/50 GEN SKLAR INSTRUMENTS 96-2562 600035 10649111059513

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown