BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIQUIBAND OPTIMA

    MDR report key: 12057166 · Received June 24, 2021

    Report

    Report Number
    9617175-2021-00024
    Event Type
    Injury
    Date Received
    June 24, 2021
    Report Date
    June 24, 2021
    Manufacturer
    ADVANCED MEDICAL SOLUTIONS LTD
    Product Code
    MPN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    117

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE CLOSURE OF A SIMPLE EYE BROW LACERATION, A YOUNG PERSON UNINTENTIONALLY HAD HIS EYELASHES GLUED TOGETHER AND RESIDUAL UNWANTED GLUE ADHERED TO HIS LID. GUIDANCE AS PER THE IFU WAS FOLLOWED. UNFORTUNATELY, DUE TO THE SENSITIVITY OF THE SITE AND YOUNG AGE OF THE PATIENT, REMOVAL ATTEMPTS BY SIMPLE IRRIGATION WITH SALINE AND SOFT PARAFFIN WERE PROLONGED. THE GLUE WAS EVENTUALLY REMOVED WITH SALINE AND VASELINE BUT UNFORTUNATELY THE CHILD SUSTAINED A SMALL CORNEAL ABRASION. 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

    DURING THE CLOSURE OF A SIMPLE EYE BROW LACERATION, A YOUNG PERSON UNINTENTIONALLY HAD HIS EYELASHES GLUED TOGETHER AND RESIDUAL UNWANTED GLUE ADHERED TO HIS LID. GUIDANCE AS PER THE IFU WAS FOLLOWED. UNFORTUNATELY, DUE TO THE SENSITIVITY OF THE SITE AND YOUNG AGE OF THE PATIENT, REMOVAL ATTEMPTS BY SIMPLE IRRIGATION WITH SALINE AND SOFT PARAFFIN WERE PROLONGED. THE GLUE WAS EVENTUALLY REMOVED WITH SALINE AND VASELINE BUT UNFORTUNATELY THE CHILD SUSTAINED A SMALL CORNEAL ABRASION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    957134 LIQUIBAND OPTIMA TOPICAL SKIN ADHESIVE MPN ADVANCED MEDICAL SOLUTIONS LTD OPT002

    Patients

    Seq Age Sex Outcome Treatment
    1 Other