BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OWENS & MINOR (HALYARD HEALTH) BACK TABLE COVER

    MDR report key: 8743690 · Received June 28, 2019

    Report

    Report Number
    1423395-2019-00022
    Event Type
    Malfunction
    Date Received
    June 28, 2019
    Date of Event
    June 1, 2019
    Report Date
    June 28, 2019
    Manufacturer
    OWENS & MINOR (HALYARD HEALTH)
    Product Code
    OJK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT DURING AN UNIDENTIFIED EYE PROCEDURE, THE OWENS & MINOR BACK TABLE COVER (BTC) WAS IDENTIFIED TO BE LINTING. REPORTEDLY, THE BTC MATERIAL LINTED INTO A PATIENT'S EYES AND THE MATERIAL WAS REQUIRED TO BE RETRIEVED. AFTER MULTIPLE GOOD-FAITH ATTEMPTS, THE REPORTING FACILITY WAS UNABLE OR UNWILLING TO PROVIDE ADDITIONAL PATIENT, PRODUCT, OR PROCEDURAL INFORMATION TO THE PACK MANUFACTURER. NO IMPACT OR ADVERSE EFFECT TO A PATIENT WAS ORIGINALLY REPORTED TO THE PACK MANUFACTURER. NO SAMPLE FOR EVALUATION WAS RETURNED TO THE PACK MANUFACTURER. A ROOT CAUSE FOR THE REPORTED INCIDENT COULD NOT BE DETERMINED. DUE TO THE REPORTED NEED FOR MEDICAL INTERVENTION TO RETRIEVE BTC MATERIAL FROM THE PATIENT'S EYES, 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 THE BACK TABLE COVER LINTED DURING AN UNIDENTIFIED EYE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    536544 OWENS & MINOR (HALYARD HEALTH) BACK TABLE COVER CATARACT PACK-OS OJK OWENS & MINOR (HALYARD HEALTH)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention