BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GOWN,SMS,WRAP,W/TWL,XL,480/CS

    MDR report key: 18340570 · Received December 15, 2023

    Report

    Report Number
    1417592-2023-00501
    Event Type
    Injury
    Date Received
    December 15, 2023
    Date of Event
    November 20, 2023
    Report Date
    December 15, 2023
    Manufacturer
    MEDLINE INDUSTRIES LP
    Product Code
    FYA
    UDI-DI
    10884389029589
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED BY THE CUSTOMER CONTACT THAT "DURING PROCEDURE THAT HAS BEEN FIND OF FIBERS IN THE EYE FROM FIBERS COMING GOWNS". IT WAS REPORTED THAT "THEY HAVE REMOVED THE FIBERS FROM THE PATIENTS' EYES DURING THE SAME SURGERY DATE WITH NO PATIENT HARM TO COMPLETE THE PROCEDURES". A SAMPLE WAS REQUESTED TO BE RETURNED FOR EVALUATION.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

    FIBERS FROM GOWN FALLING INTO PATIENT'S EYE DURING PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    886370 GOWN,SMS,WRAP,W/TWL,XL,480/CS FYA MEDLINE INDUSTRIES LP 31121060031E 10884389029589

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other