BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    ECONO STERILE¿

    MDR report key: 22117295 · Received May 30, 2025

    Report

    Report Number
    3015895045-2025-00002
    Event Type
    Malfunction
    Date Received
    May 30, 2025
    Date of Event
    April 30, 2025
    Report Date
    May 30, 2025
    Manufacturer
    SKLAR INSTRUMENTS
    Product Code
    GEN
    UDI-DI
    10649111071201
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE NOT USED ON ANY PATIENT. ISSUE DISCOVERED DURING RECEIVING INSPECTION. THERE HAVE BEEN NO COMPLAINTS ABOUT THIS DEVICE IN THE PAST TWO YEARS.

    Description of Event or Problem · 0

    ON (B)(6) 2025, (B)(6), THE PROPERTY OFFICER FOR THE (B)(6), NOTIFIED (B)(6), CUSTOMER SERVICE REPRESENTATIVE FOR (B)(4) DISTRIBUTOR (B)(4). THAT 4EA OF 96-2624 ECONO STERILE¿ SCHROEDER TENACULUM FORCEPS 10" CS/25 HAD COMPROMISED PACKAGING. THIS WAS NOTED ON INCOMING INSPECTION. THIS PRODUCT WAS NOT USED ON ANY PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36867 ECONO STERILE¿ SCHROEDER TENACULUM FORCEPS 10" CS/25 GEN SKLAR INSTRUMENTS 96-2624 600042 10649111071201

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown