BEUDAMED
    FDA Adverse Event Other Summary report: N

    DERMABOND TOPICAL SKIN ADHESIVE

    MDR report key: 854685 · Received May 21, 2007

    Report

    Report Number
    1034548-2007-00014
    Event Type
    Other
    Date Received
    May 21, 2007
    Date of Event
    April 9, 2007
    Report Date
    April 23, 2007
    Manufacturer
    CLOSURE MEDICAL CORP.
    Product Code
    MPN
    PMA / PMN Number
    960052
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SOME INFO FOR THIS REPORT HAD NOT BEEN PROVIDED AT THIS FILING. IF THE INFO IS PROVIDED AT A LATER DATE, A SUPPLEMENTAL FILING WILL BE SENT. THE EVENT DESCRIPTION DOES NOT SUGGEST THAT THE FUNCTIONAL PERFORMANCE OF THE DEVICE WAS OUT OF SPEC, BUT INDICATES A POSSIBLE SENSITIVITY REACTION. A SMALL PERCENTAGE OF THE POPULATION MAY HAVE HYPERSENSITIVITY TO THE ADHESIVE OR ITS DERIVATIVES. TYPICALLY THESE REACTIONS OCCUR IMMEDIATELY AFTER APPLICATION. WITHOUT SENSITIVITY TESTING ON THESE MATERIALS, IT IS NOT POSSIBLE TO DETERMINE IF THE REACTION WAS DUE TO THE ADHESIVE OR OTHER FACTORS. THE PACKAGE INSERT INFORMS THE USER THAT REACTIONS MAY OCCUR IN PTS WHO ARE HYPERSENSITIVE TO CYANOACRYLATE OR FORMALDEHYDE. REACTIONS IN THESE PTS ARE TYPICALLY LIMITED TO REDNESS AND/OR INFLAMMATION THAT RESOLVES WITHOUT FURTHER TREATMENT ONCE THE ADHESIVE HAS BEEN REMOVED.

    Description of Event or Problem · 1

    THE PATIENT HAD A C-SECTION ON 3/22 AND DERMABOND WAS USED TO CLOSE THE 15CM WOUND. SHE RETURNED TO THE HOSPITAL APPROX 18 DAYS LATER, SINCE SHE DEVELOPED DERMATITIS AROUND THE DERMABOND AND WAS GIVEN TEXMETEN OINTMENT. SHE VISITED A DERMATOLOGIST 10 DAYS LATER AND ANTEBATE LOTION WAS PRESCRIBED. THE PATIENT IS NOW STABLE AND RECOVERING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DERMABOND TOPICAL SKIN ADHESIVE TISSUE ADHESIVE FOR SOFT TISSUE APPROX MPN CLOSURE MEDICAL CORP. NA 106277

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other