BEUDAMED
    FDA Adverse Event Other Summary report: N

    DERMABOND TOPICAL SKIN ADHESIVE

    MDR report key: 487596 · Received October 2, 2003

    Report

    Report Number
    1034548-2003-00023
    Event Type
    Other
    Date Received
    October 2, 2003
    Date of Event
    March 7, 2003
    Report Date
    October 2, 2003
    Manufacturer
    CLOSURE MEDICAL CORP.
    Product Code
    MPN
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    PRODUCT WAS APPLIED TO A LACERATION UNDER THE EYEBROW AND EXTENDING TOWARD THE NOSE OF A PT. THREES SUTURES WERE USED ON THE LACERATION AND ON THE AREA CLOSEST TO THE NOSE, THE ATTENDING OPTED TO APPLY THE DEVICE RATHER THAN SUTURES, AS THIS WAS CLOSE TO THE EYELID. A PATCH WAS PLACED OVER THE EYE PRIOR TO APPLICATION. AFTER APPLYING THE DEVICE, THE ATTENDING REMOVED THE PATCH AND A DROP OF THE DEVICE FELL ON THE LACERATION AND EYELID. THE LID THEN BECAME BONDED SHUT. ACETONE WAS APPLIED TO TRY AND REMOVE THE DEVICE. FIVE DAYS POST APPLICATION THE SUTURES WERE REMOVED AND THE DEVICE WAS STILL ADHERING. AN OPHTHALMOLOGIST SAW THE PT AND THERE WERE NO PROBLEMS. AT THE TIME OF THIS FILING THE PT STATUS IS FINE. 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 UNKNOWN Other