BEUDAMED
    FDA Adverse Event Injury Summary report: N

    Medline Industries, Inc.

    MDR report key: 14289350 · Received May 5, 2022

    Report

    Report Number
    1423395-2022-00017
    Event Type
    Injury
    Date Received
    May 5, 2022
    Date of Event
    March 8, 2022
    Report Date
    May 4, 2022
    Manufacturer
    MEDLINE INDUSTRIES LP
    Product Code
    OJK
    UDI-DI
    10193489374445
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE FACILITY A FIBER WAS DISCOVERED POST CATARACT PROCEDURE AND NEEDED AN ADDITIONAL PROCEDURE TO REMOVE THE FIBER. PER THE FACILITY THE PATIENT'S CATARACT PROCEDURE WAS PERFORMED ON (B)(6) 2022 AND DURING A POST OP VISIT IT WAS STATED THE PATIENT HAD INFLAMMATION IN THE RIGHT EYE AND A FOREIGN BODY WAS DISCOVERED. PER THE FACILITY, SURGICAL REMOVAL WAS NEEDED IN ORDER FOR THE FOREIGN BODY TO BE REMOVED. THE PROCEDURE WAS PERFORMED ON (B)(6) 2022 AND THE FOREIGN BODY WAS REMOVED FROM THE ANTERIOR CHAMBER OF THE RIGHT EYE BY OPENING THE PRIOR INCISION FROM THE CATARACT SURGERY. NO ADDITIONAL SUTURES WERE NEEDED TO CLOSE THE INCISION AND PER THE FACILITY THEY EXPECT "EXCELLENT RECOVERY WITH NORMAL VISUAL RECOVERY". THE SAMPLE IS NOT AVAILABLE TO BE RETURNED FOR EVALUATION. NO ADDITIONAL INFORMATION IS CURRENTLY AVAILABLE. DUE TO THE REPORTED INCIDENT AND 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 A FIBER WAS DISCOVERED POST CATARACT PROCEDURE AND NEEDED AN ADDITIONAL PROCEDURE TO REMOVE THE FIBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1694287 Medline Industries, Inc. EYE PACK UPMC OJK MEDLINE INDUSTRIES LP LYN003EYUPA 21LBD671 10193489374445

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Required Intervention| O