BEUDAMED
    FDA Adverse Event Other Summary report: N

    DERMABOND TOPICAL SKIN ADHESIVE

    MDR report key: 518114 · Received March 26, 2004

    Report

    Report Number
    1034548-2004-00004
    Event Type
    Other
    Date Received
    March 26, 2004
    Date of Event
    February 17, 2004
    Report Date
    March 26, 2004
    Manufacturer
    CLOSURE MEDICAL CORP.
    Product Code
    MPN
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PRODUCT WAS USED TO CLOSE A FACIAL LACERATION ON A PT. THE PRODUCT RAN INTO THE EYE AND BONDED IT SHUT. SEVERAL DAYS LATER THE PT WAS SEEN AT THE REPORTING FACILITY WITH NAUSEA AND VOMITING ALONG WITH THE BONDED EYELID. THE PT WAS ADMITTED TO RULE OUT HEAD TRAUMA. IT WAS NOTED THAT THE ADHESIVE WAS OBSERVED BONDING THE EYELIDS TOGETHER ALONG WITH EVERSION OF THE EYELIDS. THE PT WAS PUT UNDER GENERAL ANESTHESIA AND THE PRODUCT WAS REMOVED USING AN OPHTHALMIC OINTMENT. A VITREAL RETINAL SPECIALIST EXAMINED THE EYE. PT WAS DISCHARGED WITH NO REPORTED ABRASIONS. PT WAS IN FINE CONDITION. PRODUCT WAS NOT RETURNED.

    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 * Other