BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIQUIBAND OPTIMA

    MDR report key: 12056922 · Received June 24, 2021

    Report

    Report Number
    9617175-2021-00023
    Event Type
    Injury
    Date Received
    June 24, 2021
    Date of Event
    May 5, 2021
    Report Date
    June 24, 2021
    Manufacturer
    ADVANCED MEDICAL SOLUTIONS LTD
    Product Code
    MPN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT A PATIENT THAT AFTER USE OF LIQUIBAND OPTIMA TO SUTURE A WOUND AT THE LEVEL OF THE LEFT EYEBROW ARCH, A DROP OF THE GLUE FELL IN A (B)(6)-YEAR-OLD CHILD'S EYE (NOT PROTECTED BY A COMPRESS) AND EYELIDS WERE GLUED TOGETHER. THE PATIENT WAS TRANSFERRED TO OPHTHALMOLOGICAL SURGERY DEPARTMENT. SUBSEQUENTLY THE EYELIDS WERE OPENED WITH HOT WATER AND BETADINE WITH SOAP, SOME RESIDUAL GLUE WAS REMOVED FROM THE CORNEA. A SUPERFICIAL CORNEAL ULCER WAS NOTED. THE WOUND AT THE LEVEL OF THE LEFT EYEBROW ARCH WAS CLOSED WITH STITCHES AS IT WAS STILL OPEN. THE LIQUIBAND OPTIMA IFU HAS THE FOLLOWING WARNING IDENTIFIED IN THE IFU WHICH INDICATES A METHOD OF PREVENTION FOR THIS INCIDENT- 'USE OF CYANOACRYLATE TISSUE ADHESIVE NEAR THE EYE HAS INADVERTENTLY CAUSED SOME PATIENT'S EYELIDS TO BE SEALED SHUT. WHEN CLOSING FACIAL WOUNDS NEAR THE EYE, PLEASE POSITION THE PATIENT SO THAT ANY RUNOFF OF ADHESIVE IS AWAY FROM THE EYE. THE EYE SHOULD BE CLOSED AND PROTECTED WITH GAUZE. PROPHYLACTIC PLACEMENT OF PETROLEUM JELLY AROUND THE EYE, TO ACT AS A MECHANICAL BARRIER OR DAM, CAN BE EFFECTIVE AT PREVENTING INADVERTENT FLOW OF ADHESIVE INTO THE EYE.' AS THE IFU INDICATES THE METHOD TO AVOID ACCIDENTAL DISCHARGE OF GLUE INTO EYES, THIS EVENT IS DETERMINED TO BE A USER ERROR.

    Description of Event or Problem · 1

    USE OF LIQUIBAND OPTIMA TO SUTURE A WOUND AT THE LEVEL OF THE LEFT EYEBROW ARCH. A DROP OF THE GLUE FELL IN A (B)(6)-YEAR-OLD CHILD'S EYE (NOT PROTECTED BY A COMPRESS) AND EYELIDS WERE GLUED TOGETHER. THE PATIENT WAS TRANSFERRED TO OPHTHALMOLOGICAL SURGERY DEPARTMENT. SUBSEQUENTLY THE EYELIDS WERE OPENED WITH HOT WATER AND BETADINE WITH SOAP, SOME RESIDUAL GLUE WAS REMOVED FROM THE CORNEA. A SUPERFICIAL CORNEAL ULCER WAS NOTED. SUBSEQUENTLY THE EYELIDS WERE OPENED WITH HOT WATER AND BETADINE WITH SOAP, SOME RESIDUAL GLUE WAS REMOVED FROM THE CORNEA. THE WOUND AT THE LEVEL OF THE LEFT EYEBROW ARCH WAS CLOSED WITH STITCHES AS IT WAS STILL OPEN. VITAMINE A®, TOBRADEX® AND STERIDOSE® WERE PRESCRIBED AFTER THE SURGERY TO TREAT CORNEAL ULCER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    954784 LIQUIBAND OPTIMA TOPICAL SKIN ADHESIVE MPN ADVANCED MEDICAL SOLUTIONS LTD OPT002 P00221084

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Other