BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDLINE

    MDR report key: 24967487 · Received April 23, 2026

    Report

    Report Number
    1423395-2026-00092
    Event Type
    Malfunction
    Date Received
    April 23, 2026
    Date of Event
    April 3, 2026
    Report Date
    May 28, 2026
    Manufacturer
    MEDLINE INDUSTRIES, LP - SPT
    Product Code
    OGR
    UDI-DI
    10198459353680
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED ON 04/03 THAT DURING SURGICAL FIELD SETUP, SMALL COTTON LIKE BALL WAS NOTED ON THE RAYTEC PRIOR TO USE. THERE WERE NO REPORTS OF DEATH, SERIOUS INJURY, MEDICAL INTERVENTION, OR FOLLOW UP CARE. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT COULD CAUSE OR CONTRIBUTE TO SERIOUS INJURY IF IT WERE TO OCCUR AGAIN. 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

    IT WAS REPORTED ON 04/03 THAT DURING SURGICAL FIELD SETUP, SMALL COTTON LIKE BALL WAS NOTED ON THE RAYTEC PRIOR TO USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343165 MEDLINE RR-ASC THYROID PACK OGR MEDLINE INDUSTRIES, LP - SPT 26AMH444 10198459353680

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown