BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APPLICATOR,COTTON-TIP,PLASTIC,6",STERILE

    MDR report key: 10268220 · Received July 13, 2020

    Report

    Report Number
    1417592-2020-00073
    Event Type
    Malfunction
    Date Received
    July 13, 2020
    Date of Event
    June 1, 2020
    Report Date
    July 13, 2020
    Manufacturer
    MEDLINE INDUSTRIES INC.
    Product Code
    KXG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT ON AN UNSPECIFIED DATE THE COTTON TIP OF A STERILE 6" PLASTIC APPLICATOR CAME OFF/BROKE OFF INSIDE A PATIENT'S INCISION DURING SURGERY. THE REPORTER STATES THE INCISION HAD TO BE EXTENDED TO SEARCH FOR THE STERILE COTTON TIP. DUE DILIGENCE HAS BEEN COMPLETED. NO ADDITIONAL DETAILS ARE AVAILABLE RELATED TO THE CUSTOMER REPORTED ISSUE. DESPITE MULTIPLE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE CUSTOMER CONTACT WAS UNABLE OR UNWILLING TO PROVIDE FURTHER INCIDENT DETAILS TO THE MANUFACTURER. THE SAMPLE HAS NOT BEEN RETURNED. DUE TO THE REPORTED NATURE OF THE INCIDENT, AND THE REPORTED MEDICAL INTERVENTION THIS MEDWATCH IS BEING FILE. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE REOPENED AND REEVALUATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE TIP OF A STERILE COTTON TIPPED 6" PLASTIC APPLICATOR CAME OFF INSIDE A PATIENT'S INCISION DURING SURGERY. THE INCISION HAD TO BE EXTENDED TO SEARCH FOR COTTON TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726536 APPLICATOR,COTTON-TIP,PLASTIC,6",STERILE KXG MEDLINE INDUSTRIES INC. 21619090001

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R