BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APPLICATOR,COTTON-TIP,PLASTIC,6,STERILE

    MDR report key: 18297385 · Received December 8, 2023

    Report

    Report Number
    1417592-2023-00493
    Event Type
    Injury
    Date Received
    December 8, 2023
    Date of Event
    November 8, 2023
    Report Date
    January 5, 2024
    Manufacturer
    MEDLINE INDUSTRIES, LP
    Product Code
    KXG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATE H6: INVESTIGATION CONCLUSIONS.

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE CUSTOMER, ON (B)(6) 2023 WHEN USING THE COTTON APPLICATOR TO PACK A WOUND THE TIP "DISLODGED IN THE TUNNEL" OF THE WOUND. THE CUSTOMER REPORTED THAT THE TIP WAS RETRIEVED WITH "IRRIGATION AND PACKING REMOVAL" AND THE WOUND CARE WAS ABLE TO BE COMPLETED USING A DIFFERENT PRODUCT. THE CUSTOMER REPORTED THE PATIENT IS "STABLE". SAMPLE REQUESTED FOR RETURN EVALUATION. 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

    ACCORDING TO THE CUSTOMER, ON (B)(6) 2023 WHEN USING THE COTTON APPLICATOR TO PACK A WOUND THE TIP "DISLODGED IN THE TUNNEL" OF THE WOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54187 APPLICATOR,COTTON-TIP,PLASTIC,6,STERILE KXG MEDLINE INDUSTRIES, LP 2952211004

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other