BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDLINE INDUSTRIES, INC.

    MDR report key: 10401234 · Received August 13, 2020

    Report

    Report Number
    1423395-2020-00022
    Event Type
    Injury
    Date Received
    August 13, 2020
    Date of Event
    July 30, 2020
    Report Date
    August 13, 2020
    Manufacturer
    MEDLINE INDUSTRIES INC.
    Product Code
    LRO
    UDI-DI
    10193489236583
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT TWO SEPARATE PATIENTS WERE UNDERGOING CATARACT SURGERY AND AT THE END OF THE PROCEDURE FIBERS FROM THE BLUE OR TOWEL WERE NOTED IN THE PATIENT'S EYE (THIS REPORT ADDRESSES PATIENT #1). THE DOCTOR WAS ABLE TO REMOVE THE FIBERS WITH IRRIGATION AND FORCEPS WITH NO ADDITIONAL INTERVENTION REQUIRED. THERE WAS NO IMPACT ON THE PATIENT'S STABILITY OR OUTCOME RELATED TO THE REPORTED ISSUE. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER INCIDENT OR DELAY. THE CUSTOMER IS REPORTEDLY DOING FINE WITH NO TROUBLES NOTED NO FOLLOW UP TREATMENT WAS REQUIRED. THE SAMPLE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. NO ROOT CAUSE COULD BE DETERMINED. NO ADDITIONAL INFORMATION IS 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 · 1

    IT WAS REPORTED THAT A PATIENT WAS UNDERGOING CATARACT SURGERY AND AT THE END OF THE PROCEDURE FIBERS FROM THE BLUE OR TOWEL WERE NOTED IN THE PATIENT'S EYE REQUIRING REMOVAL BY THE DOCTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    865520 MEDLINE INDUSTRIES, INC. BOOZMAN HOF PACK 2 LRO MEDLINE INDUSTRIES INC. VAL042EYBHA 10193489236583

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention