BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    ECONO STERILE¿

    MDR report key: 22117620 · Received May 30, 2025

    Report

    Report Number
    3015895045-2025-00003
    Event Type
    Malfunction
    Date Received
    May 30, 2025
    Date of Event
    January 28, 2025
    Report Date
    May 30, 2025
    Manufacturer
    SKLAR INSTRUMENTS
    Product Code
    LRW
    UDI-DI
    50649111316140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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, ONE OF SKLAR'S DISTRIBUTORS REACHED OUT TO CUSTOMER SERVICE REGARDING AN ISSUE WITH A HOLE IN THE STERILE PACKAGING OF (B)(4) OF 96-2650 ECONO STERILE¿ IRIS SCISSORS - 4-1/2", STRAIGHT, SHARP/SHARP CS/100. 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
    773235 ECONO STERILE¿ IRIS SCISSORS - 4-1/2", STRAIGHT, SHARP/SHARP CS/100 LRW SKLAR INSTRUMENTS 96-2650 600026 50649111316140

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown