BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GAUZE FROM EYE PACK

    MDR report key: 8147723 · Received December 10, 2018

    Report

    Report Number
    1423395-2018-00063
    Event Type
    Malfunction
    Date Received
    December 10, 2018
    Date of Event
    November 26, 2018
    Report Date
    December 10, 2018
    Manufacturer
    MEDLINE INDUSTRIES INC.
    Product Code
    OJK
    UDI-DI
    10888277799905
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT AT THE BEGINNING OF THE EYE/CATARACT/IOL/IMPLANT PROCEDURE, WHEN THE PATIENT'S EYE WAS LOOKED AT UNDER A MICROSCOPE, IT WAS DISCOVERED BY THE PHYSICIAN THAT THERE WAS A LINT PARTICULATE FLOATING ON PATIENT'S LENS. THE LINT PARTICULATE WAS REPORTEDLY POSSIBLY FROM THE GAUZE LOCATED IN THE PREP TRAY FROM THE CUSTOM SURGICAL PACK (EYE PACK). IT WAS ADDED THAT THE LINT PARTICULATE REACHED THE PATIENT'S EYE/LENS WHEN MEDICATION FROM THE MEDICINE CUP WAS ADMINISTERED TO THE PATIENT'S EYE. PER REPORT, THE CUSTOM SURGICAL PACK'S INTEGRITY WAS VERIFIED PRIOR TO USE AND THE LINT PARTICULATE WAS NOT IDENTIFIED IN THE MEDICINE CUP AT THAT TIME. IT WAS REPORTED THAT IRRIGATION WAS REQUIRED TO REMOVE THE LINT PARTICULATE FROM THE PATIENT'S EYE/LENS. THE PATIENT WAS UNDER SEDATION AT THE TIME OF THE INCIDENT AND THERE WAS NO REPORT OF ADDITIONAL SEDATION MEDICATION REQUIRED. IMMEDIATELY IN THE POST-OPERATIVE PHASE, THE PATIENT WAS REPORTEDLY WELL. NO IMPACT TO THE PATIENT, THE PROCEDURE, OR THE TOTAL LENGTH OF THE PROCEDURE WAS REPORTED. THERE WAS NO SERIOUS INJURY OR FOLLOW UP CARE REPORTED RELATED TO THE EVENT. DUE TO THE REPORTED INCIDENT AND MEDICAL INTERVENTION, THIS MEDWATCH IS BEING FILED. THE SAMPLE IS NOT AVAILABLE TO BE RETURNED FOR EVALUATION. A ROOT CAUSE COULD NOT BE DETERMINED AT THIS TIME. NO ADDITIONAL INFORMATION IS AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IRRIGATION WAS REQUIRED TO REMOVE THE LINT PARTICULATE THAT WAS DISCOVERED FLOATING ON THE PATIENT'S LENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    986088 GAUZE FROM EYE PACK OJK MEDLINE INDUSTRIES INC. 18HDB581 10888277799905

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention