BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    ECONO STERILE¿

    MDR report key: 22730949 · Received August 6, 2025

    Report

    Report Number
    2431166-2025-00009
    Event Type
    Malfunction
    Date Received
    August 6, 2025
    Date of Event
    August 1, 2025
    Report Date
    August 6, 2025
    Manufacturer
    SKLAR INSTRUMENTS
    Product Code
    GEN
    UDI-DI
    10649111056802
    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 (B)(6) 2025, ONE OF SKLAR'S DISTRIBUTORS REACHED OUT TO CUSTOMER SERVICE REGARDING AN ISSUE WITH A HOLE IN THE STERILE PACKAGING OF 1 EA OF 96-2549 ECONO STERILE¿ ROCHESTER-PEAN FORCEPS, CURVED, 8 1/2" 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
    1529142 ECONO STERILE¿ ECONO STERILE¿ ROCHESTER-PEAN FORCEPS, CURVED, 8 1/2" CS/50, GEN SKLAR INSTRUMENTS 96-2549 600031 10649111056802

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown