BEUDAMED
    FDA Adverse Event Other Summary report: N

    DERMABOND TOPICAL SKIN ADHESIVE

    MDR report key: 384751 · Received March 22, 2002

    Report

    Report Number
    1034548-2002-00013
    Event Type
    Other
    Date Received
    March 22, 2002
    Date of Event
    February 2, 2002
    Report Date
    March 22, 2002
    Manufacturer
    CLOSURE MEDICAL CORPORATION
    Product Code
    MPN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    ACCORDING TO THE DISTRIBUTOR REPORT, DERMABOND ADHESIVE WAS USED TO CLOSE A FACIAL LACERATION. THE PT WAS SEATED IN FAMILY MEMBER'S LAP AT THE DR'S OFFICE. NO DRAPING WAS PLACED ON THE AREA TO BE TREATED. NO APPLICATION OF PETROLEUM JELLY OR OINTMENT WAS PLACED AROUND THE EYE PRIOR TO APPLICATION; NO GAUZE OR BARRIER WAS PLACED OVER THE EYE PRIOR TO APPLICATION. DURING APPLICATION, THE ADHESIVE DRIPPED DOWN TO THE EYE CAUSING IT TO GLUE THE EYELID SHUT. THE FAMILY MEMBER WAS INSTRUCTED TO APPLY PETROLEUM JELLY TO THE EYELID AFTER 2 TO 3 DAYS. THE FOLLOWING DAY THE FAMILY MEMBER CALLED THE DR'S OFFICE BECAUSE THEY WERE UNCOMFORTABLE WITH WAITING AND WAS INSTRUCTED TO GO TO THE EMERGENCY ROOM. THE ER STAFF COULD NOT OPEN THE EYELID AND REFERRED THEM TO AN OPTHALMOLOGIST. IN 2002, THE PT SAW AN OPTHALMOLOGIST WHO "PRYED OPEN" THE EYELID AFTER RUBBING IT WITH OINTMENT. THE PT'S CORNEA WAS "SCRATCHED." THE OPTHALMOLOGIST PRESCRIBED DROPS AND OINTMENT. PT WAS EXAMINED THE NEXT DAY BY THE OPTHALMOLOGIST AND THE CORNEA IS REPORTED AS HEALING.

    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 CORPORATION NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 18 MO Other