BEUDAMED
    FDA Adverse Event Other Summary report: N

    DERMABOND TOPICAL SKIIN ADHESIVE

    MDR report key: 376959 · Received February 13, 2002

    Report

    Report Number
    1034548-2002-00012
    Event Type
    Other
    Date Received
    February 13, 2002
    Date of Event
    January 24, 2002
    Report Date
    February 13, 2002
    Manufacturer
    CLOSURE MEDICAL CORP.
    Product Code
    MPN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    ACCORDING TO THE DISTRIBUTOR REPORT, DERMABOND(R) ADHESIVE WAS USED TO CLOSE A LACERATION TO THE AREA ABOVE THE EYE. THE AREA WAS NOT DRAPED OR COVERED WITH GAUZE. NEOSPORIN OINTMENT WAS APPLIED TO THE AREA AROUND THE EYE PRIOR TO THE APPLICATION. PT WAS LYING ON THEIR BACK DURING THE APPLICATION. PT'S EYELIDS WERE SHUT; THE ADHESIVE RAN INTO THE CORNER OF PT'S EYE RESULTING IN THE EYE GLUED SHUT. FAMILY MEMBER TOOK THE PT TO AN OPTHALMOLOGIST 5 DAYS AFTER THE EVENT WHO CUT THE PT'S EYELASHES AND ADVISED APPLICATION OF PETROLEUM JELLY TO LOOSEN THE ADHESIVE. OVER THE PAST FEW DAYS THE EYELID HAS OPENED. FURTHER OPTHALMOLOGIC EXAMINATION REVEALED NO INJURY TO THE EYE, NO ABRASION OR APPARENT LOSS OF VISION. PT IS TO FOLLOW UP WITH THE OPTHALMOLOGIST IN TWO MONTHS TO EVALUATE GROWTH OF EYELASHES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DERMABOND TOPICAL SKIIN ADHESIVE TISSUE ADHESIVE FOR SOFT TISSUE APPROXIMATION MPN CLOSURE MEDICAL CORP. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Other