BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATARACT PACK

    MDR report key: 8019476 · Received October 30, 2018

    Report

    Report Number
    1423395-2018-00057
    Event Type
    Malfunction
    Date Received
    October 30, 2018
    Date of Event
    October 1, 2018
    Report Date
    October 30, 2018
    Manufacturer
    MEDLINE INDUSTRIES INC.
    Product Code
    OJK
    UDI-DI
    10889942106028
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT DURING AN UNIDENTIFIED OPHTHALMIC PROCEDURE, FIBERS FROM AN UNIDENTIFIED COMPONENT WERE FOUND TO HAVE FALLEN INTO THE PATIENT'S EYE. THE FACILITY WAS CONTACTED AND WAS UNABLE TO IDENTIFY IF THE FIBERS CAME FROM A GOWN OR AN OPERATING ROOM TOWEL. THE FACILITY NOTED THAT THERE WAS NO PATIENT IMPACT RELATED TO THIS INCIDENT AND THAT THEY ARE UNABLE OR UNWILLING TO PROVIDE ANY ADDITIONAL PATIENT, PRODUCT, OR PROCEDURAL INFORMATION. IT WAS NOT IDENTIFIED WHICH EYE THE FIBERS FELL ON. IT WAS NOT IDENTIFIED HOW THE FIBERS WERE RETRIEVED. NO PROCEDURAL IMPACT, SERIOUS INJURY, OR FOLLOW-UP CARE WAS ORIGINALLY REPORTED TO THE MANUFACTURER. A SAMPLE OF UNOPENED OPERATING ROOM TOWELS WAS RETURNED TO THE MANUFACTURER AND LINT WAS NOTED ON THE OPERATING ROOM TOWELS ONLY. IT IS UNKNOWN HOW THE OPERATING ROOM TOWELS WERE USED DURING THE PROCEDURE. NO SAMPLE OF A GOWN WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. IT IS UNKNOWN AT WHAT POINT IN THE PROCEDURE THE FIBERS WERE IDENTIFIED. A ROOT CAUSE FOR THE REPORTED INCIDENT COULD NOT BE DETERMINED. DUE TO THE REPORTED INCIDENT, AND IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNIDENTIFIED OPHTHALMIC PROCEDURE, FIBERS FROM AN UNIDENTIFIED COMPONENT WERE FOUND TO HAVE FALLEN INTO THE PATIENT'S EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    861450 CATARACT PACK OJK MEDLINE INDUSTRIES INC. 18NB3371 10889942106028

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R