BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THE SURGERY CENTER CATARACT

    MDR report key: 19822185 · Received July 24, 2024

    Report

    Report Number
    1423395-2024-00446
    Event Type
    Injury
    Date Received
    July 24, 2024
    Date of Event
    April 12, 2024
    Report Date
    July 24, 2024
    Manufacturer
    MEDLINE INDUSTRIES LP
    Product Code
    OJK
    UDI-DI
    40195327250417
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE FACILITY, "WE HAVE REMOVED THE TOWELS AND MED CUPS IN THE PACK DUE TO EXTREME FIBERS. WE HAVE ACTUALLY TRANSFERRED FIBER INTO THE PATIENT'S EYE DUE TO THIS ISSUE". THERE WAS NO FURTHER INFORMATION. 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 FACILITY, "WE HAVE REMOVED THE TOWELS AND MED CUPS IN THE PACK DUE TO EXTREME FIBERS. WE HAVE ACTUALLY TRANSFERRED FIBER INTO THE PATIENT'S EYE DUE TO THIS ISSUE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2370901 THE SURGERY CENTER CATARACT OJK MEDLINE INDUSTRIES LP 24ABN974 40195327250417

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other