BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DERMABOND 2

    MDR report key: 2991519 · Received March 6, 2013

    Report

    Report Number
    2210968-2013-02115
    Event Type
    Injury
    Date Received
    March 6, 2013
    Date of Event
    February 12, 2013
    Report Date
    February 12, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    MPN
    PMA / PMN Number
    P960052
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PEDIATRIC PATIENT WAS SEEN IN THE EMERGENCY ROOM BECAUSE OF A LACERATION ON THE SIDE OF HIS HEAD BETWEEN THE EYE AND TEMPLE AREA. THE CHILD HAD TOPICAL SKIN ADHESIVE APPLIED TO THE LACERATION IN THE EMERGENCY ROOM AND THE CHILD'S EYE WAS GLUED SHUT. THE EMERGENCY ROOM STAFF APPLIED OINTMENT AND THE CHILD IS GOING TO SEE AN OPHTHALMOLOGIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96007 DERMABOND 2 ADHESIVE, TOPICAL SKIN MPN ETHICON, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention