BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APPLICATOR,COTTON-TIP,PLASTIC,6,STERILE

    MDR report key: 21472480 · Received February 26, 2025

    Report

    Report Number
    1417592-2025-00108
    Event Type
    Injury
    Date Received
    February 26, 2025
    Date of Event
    January 29, 2025
    Report Date
    February 26, 2025
    Manufacturer
    MEDLINE INDUSTRIES LP
    Product Code
    KXG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE DEVICE WAS BEING USED "DURING A PROCEDURE AND THE COTTON CAME OFF THEN GOT STUCK. THEY HAD TO SEND THEM TO ANOTHER PERSON TO GET IT EXTRACTED". NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT CAUSED OR CONTRIBUTED TO SERIOUS INJURY, THEREFORE, 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

    TIP CAME OFF DURING PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    540417 APPLICATOR,COTTON-TIP,PLASTIC,6,STERILE KXG MEDLINE INDUSTRIES LP 29523100003

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other