BEUDAMED
    FDA Adverse Event Injury Summary report: N

    Medline Industries, Inc.

    MDR report key: 17248193 · Received July 3, 2023

    Report

    Report Number
    1423395-2023-00032
    Event Type
    Injury
    Date Received
    July 3, 2023
    Date of Event
    June 16, 2023
    Report Date
    July 3, 2023
    Manufacturer
    MEDLINE INDUSTRIES, LP
    Product Code
    FDE
    UDI-DI
    10195327183462
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE FACILITY ON (B)(6) 2023 DURING A PROCEDURE THE GAUZE BEGAN TO FRAY WHILE INSIDE THE PATIENT. PER THE FACILITY THE GAUZE HAD TO BE REMOVED FROM THE PATIENT "WITH INSTRUMENTATION DURING A ROBOTIC PROCEDURE". PER THE FACILITY THE PRODUCT WAS INSPECTED PRIOR TO USE AND WAS BEING USED FOR "HEMOSTASIS". PER THE FACILITY AN "INTRAOP X-RAY WAS COMPLETED AND ALL REMNANTS WERE COLLECTED". NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THE SAMPLE WAS REQUESTED FOR EVALUATION. 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 ON (B)(6) 2023 DURING A PROCEDURE THE GAUZE BEGAN TO FRAY WHILE INSIDE THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26639 Medline Industries, Inc. LAP DONOR NEPHRECTOMY KIT FDE MEDLINE INDUSTRIES, LP DYNJ908787 23DDB156 10195327183462

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other