BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRAY,SKIN SCRUB,DRY,W/GAUZE

    MDR report key: 18609158 · Received January 30, 2024

    Report

    Report Number
    1417592-2024-00044
    Event Type
    Injury
    Date Received
    January 30, 2024
    Date of Event
    December 29, 2023
    Report Date
    January 30, 2024
    Manufacturer
    MEDLINE INDUSTRIES, LP
    Product Code
    OJU
    UDI-DI
    10080196813841
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE CUSTOMER, ON 12/29/2023 DURING AN "ENT PROCEDURE", THE GAUZE WAS USED TO APPLY "HIBICLENS" TO THE INCISION SITE "PRIOR TO THE INCISION BEING MADE" AND THE "GAUZED FRAYED". THE CUSTOMER REPORTED THEY TRIED "TO REMOVE THE FIBERS FROM THE SKIN BEFORE MAKING THE INCISION". THE CUSTOMER REPORTED A "POSSIBILITY OF RETAINED FRAGMENTS IF THEY WERE NOT ALL REMOVED BY THE SURGEON AND SURGICAL TEAM" BUT, THEY WERE UNABLE TO CONFIRM IF THE GAUZE FRAGMENTS WERE LEFT IN THE INCISION. THE CUSTOMER REPORTED THEY ARE UNABLE TO DETERMINE IF THERE WERE ANY NEGATIVE OUTCOMES FOR THE PATIENT RELATED TO THE REPORTED INCIDENT. THE CUSTOMER DID NOT REPORT ANY SERIOUS INJURY, MEDICAL INTERVENTION, OR FOLLOW UP CARE RELATED TO THE REPORTED INCIDENT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. 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 12/29/2023 DURING AN "ENT PROCEDURE", THE GAUZE WAS USED TO APPLY "HIBICLENS" TO THE INCISION SITE "PRIOR TO THE INCISION BEING MADE" AND THE "GAUZED FRAYED".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392856 TRAY,SKIN SCRUB,DRY,W/GAUZE OJU MEDLINE INDUSTRIES, LP 10080196813841

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other