BEUDAMED
    FDA Adverse Event Other Summary report: N

    DERMABOND TOPICAL SKIN ADHESIVE

    MDR report key: 508230 · Received January 1, 2004

    Report

    Report Number
    1034548-2003-00030
    Event Type
    Other
    Date Received
    January 1, 2004
    Date of Event
    November 22, 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

    PRODUCT WAS USED TO CLOSE A LACERATION ON THE BRIDGE OF THE NOSE OF A PT OF UNK GENDER. THE PRODUCT RAN INTO THE LEFT EYE AND BONDED IT SHUT. THE EYE WAS OPENED AND TREATED WITH OPHTHALMIC OINTMENT AND AN OPHTHALMOLOGIST WAS CONSULTED. AT THIS TIME NO ADDITIONAL INFO HAS BEEN PROVIDED. 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 14 MO Other