BEUDAMED
    FDA Adverse Event Other Summary report: N

    DERMABOND TOPICAL SKIN ADHESIVE

    MDR report key: 508213 · Received January 1, 2004

    Report

    Report Number
    1034548-2003-00031
    Event Type
    Other
    Date Received
    January 1, 2004
    Date of Event
    November 28, 2003
    Report Date
    January 1, 2004
    Manufacturer
    CLOSURE MEDICAL CORP.
    Product Code
    MPN
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PRDUCT WAS USED TO CLOSE A SUPRAORBITAL LACERATION ON A PT OF UNK GENDER. THE PRODUCT RAN INTO THE INNER CANTHUS OF THE EYE AND BONDED IT SHUT. THE PHYSICIAN WAS UNABLE TO OPEN THE EYELIDS, HE WAS ADVISED TO APPLY A PETROLEUM BASED OPHTHALMIC OINTMENT TO THE AREA TO HELP LOOSEN THE BOND. AT THIS TIME NO ADDITIONAL INFO HAS BEEN PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other