BEUDAMED
    FDA Adverse Event Other Summary report: N

    DERMABOND TOPICAL SKIN ADHESIVE

    MDR report key: 377007 · Received February 13, 2002

    Report

    Report Number
    1034548-2002-00009
    Event Type
    Other
    Date Received
    February 13, 2002
    Date of Event
    January 20, 2002
    Report Date
    February 13, 2002
    Manufacturer
    CLOSURE MEDICAL CORP.
    Product Code
    MPN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    ACCORDING TO THE DISTRIBUTOR REPORT, DERMABOND(R) ADHESIVE WAS APPLIED TO A FOREHEAD LACERATION. DURING THE PROCEDURE, THE PT MOVED AND THE ADHESIVE GOT ON PT'S EYELASHES AND GLUED THEM SHUT. THE PT WAS SENT HOME WITH INSTRUCTIONS TO PUT PETROLEUM JELLY ON THE AREA. PARENT WAS UNSUCCESSFUL REMOVING THE ADHESIVE. THE PT RETURNED TO THE ER THE NEXT DAY AND A PHYSICIAN REMOVED THE ADHESIVE FROM THE EYELASHES AND EYELID. THE PT SUBSEQUENTLY VISITED AN OPTHALMOLOGIST WHO TOLD PT THAT THE EYE SHOWED IRRITATION AND IS BLOOD SHOT, BUT DID NOT EXHIBIT ANY DAMAGE OR REQUIRE TREATMENT. FAMILY MEMBER REPORTS THAT PT IS FINE NOW.

    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 7 YR Other