BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CATARACT PACK BOSWELL

    MDR report key: 20042159 · Received August 22, 2024

    Report

    Report Number
    1423395-2024-00460
    Event Type
    Injury
    Date Received
    August 22, 2024
    Date of Event
    May 24, 2024
    Report Date
    August 22, 2024
    Manufacturer
    MEDLINE INDUSTRIES LP
    Product Code
    OJK
    UDI-DI
    40195327029075
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE CUSTOMER, "THE CUSTOMER REPORTED THEIR MED CUPS HAVE TINY WHITE FIBERS THAT ARE ALL OVER THEM. THIS IS CAUSING ISSUES AS SEVERAL TIMES THESE FIBERS ARE GETTING ON THE INSTRUMENTS AND, ENDING UP INSIDE THE PATIENT'S EYE. THERE HAS BEEN NO PATIENT HARM AND THE FIBER/FIBERS ARE REMOVED WITH I/A". IT HAS BEEN DETERMINED THAT THE REPORTED EVENT COULD CAUSE OR CONTRIBUTE TO SERIOUS INJURY IF IT WERE TO OCCUR. IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ACCORDING TO THE CUSTOMER, "THE CUSTOMER REPORTED THEIR MED CUPS HAVE TINY WHITE FIBERS THAT ARE ALL OVER THEM. THIS IS CAUSING ISSUES AS SEVERAL TIMES THESE FIBERS ARE GETTING ON THE INSTRUMENTS AND ENDING UP INSIDE THE PATIENT'S EYE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1362851 CATARACT PACK BOSWELL OJK MEDLINE INDUSTRIES LP 24CBK355 40195327029075

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other