BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DERMABOND 2

    MDR report key: 2840442 · Received November 20, 2012

    Report

    Report Number
    2210968-2012-07520
    Event Type
    Injury
    Date Received
    November 20, 2012
    Report Date
    November 1, 2012
    Manufacturer
    ETHICON, INC.
    Product Code
    MPN
    PMA / PMN Number
    P960052
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: THE DEVICE INFORMATION FOR USE WARNS "WHEN CLOSING FACIAL WOUNDS NEAR THE EYE WITH DERMABOND ADHESIVE, POSITION THE PATIENT SO THAT ANY RUNOFF OF ADHESIVE IS AWAY FROM THE EYE. THE EYE SHOULD BE CLOSED AND PROTECTED WITH GAUZE. PROPHYLACTIC PETROLEUM JELLY AROUND THE EYE AROUND THE EYE, TO ACT AS A MECHANICAL BARRIER OR DAM, CAN BE EFFECTIVE IN PREVENTING INADVERTENT FLOW OF ADHESIVE INTO THE EYE."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PEDIATRIC PATIENT WAS SEEN IN THE EMERGENCY ROOM FOR A LACERATION. THE LACERATION WAS CLOSED USING TOPICAL SKIN ADHESIVE. WHILE APPLYING, SOME OF THE ADHESIVE GOT INTO THE PATIENT'S EYE. THE PATIENT WAS REFERRED TO AN OPHTHALMOLOGY CLINIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DERMABOND 2 ADHESIVE, TOPICAL SKIN MPN ETHICON, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention