BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SKLAR

    MDR report key: 22115730 · Received May 30, 2025

    Report

    Report Number
    3015895045-2025-00001
    Event Type
    Malfunction
    Date Received
    May 30, 2025
    Date of Event
    March 11, 2025
    Report Date
    May 30, 2025
    Manufacturer
    SKLAR INSTRUMENTS
    Product Code
    GEN
    UDI-DI
    50649111316140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    OUR CUSTOMER, (B)(4), REPORTED HOLES IN THE STERILE PACKAGING OF PRODUCT 94-6809 ROCHESTER PEAN FORCEPS CURVED 8 1/2" CS/50. LOT #S 600010 X7EA, 600012 X6EA, 600013 X9EA, 600014 X6EA. THESE WERE NOTED ON INCOMING INSPECTION. THESE PRODUCTS WERE NOT USED ON ANY PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    666844 SKLAR ROCHESTER PEAN FORCEPS CURVED 8 1/2" CS/50 GEN SKLAR INSTRUMENTS 94-6809 600010, 600012, 600013, 600014 50649111316140

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown