BEUDAMED
    FDA Adverse Event Other Summary report: N

    DERMABOND TOPICAL SKIN ADHESIVE

    MDR report key: 646876 · Received November 10, 2005

    Report

    Report Number
    1034548-2005-00030
    Event Type
    Other
    Date Received
    November 10, 2005
    Date of Event
    October 11, 2005
    Report Date
    November 8, 2005
    Manufacturer
    CLOSURE MEDICAL CORP.
    Product Code
    MPN
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    FROM THE DISTRIBUTOR'S REPORT: 1) THE REPORTER STATES THAT NO PROTECTICE BARRIERS WERE IN PLACE DURING USE. 2) THE PRODUCT WAS REMOVED BY Q-TIP AND WATER TO RELEASE. 3) THE PATIENT'S CURRENT CONDITION IS FINE.

    Description of Event or Problem · 1

    PRODUCT WAS USED TO REPAIR A PEDIATRIC LACERATION ON THE FOREHEAD. THE PRODUCT CAME INTO CONTACT WITH THE GAUZE AND EYELASHES. THE ATTENDING REMOVED GAUZE AND ADHERENT EYELASHES. THE USE OF PREVENTATIVE MEASURES AROUND THE EYE WERE NOT REPORTED. THE PT'S CURRENT CONDITION IS UNK.

    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 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other