BEUDAMED
    FDA Adverse Event Other Summary report: N

    DERMABOND TOPICAL SKIN ADHESIVE

    MDR report key: 379495 · Received February 27, 2002

    Report

    Report Number
    1034548-2002-00014
    Event Type
    Other
    Date Received
    February 27, 2002
    Date of Event
    February 12, 2002
    Report Date
    February 26, 2002
    Manufacturer
    CLOSURE MEDICAL CORP.
    Product Code
    MPN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ACCORDING TO INFORMATION SUPPLIED BY THE DISTRIBUTOR, DERMABOND TOPICAL SKIN ADHESIVE WAS APPLIED WHILE THE PATIENT WAS SITTING UPRIGHT, WITH THE PATIENT'S HEAD TILTED BACK. THERE WAS NO PHYSICAL BARRIER TO PREVENT THE PRODUCT FROM RUNNING INTO THE EYE AREA. PRODUCT WAS APPLIED IN 2002 BECAUSE OF THE EYE BONDING, AND WAS REFERRED TO AN OPHTHAMOLOGIST. HIS OFFICE INDICATED THAT THE PATIENT WAS LAST SEEN ONE WEEK AGO AND THE EYE WAS OPEN AND FINE.

    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 09 YR Other