BEUDAMED
    FDA Adverse Event Other Summary report: N

    DERMABOND TOPICAL SKIN ADHESIVE

    MDR report key: 1082499 · Received July 22, 2008

    Report

    Report Number
    1034548-2008-00019
    Event Type
    Other
    Date Received
    July 22, 2008
    Date of Event
    June 23, 2008
    Report Date
    June 23, 2008
    Manufacturer
    CLOSURE MEDICAL CORP.
    Product Code
    MPN
    PMA / PMN Number
    960052
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SOME INFORMATION FOR THIS REPORT MAY NOT HAVE BEEN PROVIDED AT THIS FILING. IF THE INFORMATION 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 SPECIFICATION, BUT INDICATES A POSSIBLE SENSITIVITY 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 PATIENTS WHO ARE HYPERSENSITIVE TO CYANOACRYLATE OR FORMALDEHYDE. REACTIONS IN THESE PATIENTS 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 DR'S OFFICE REPORTED THAT THE PATIENT PRESENTED FOR THE ONE WEEK POST-OP CHECK UP WITH REDNESS, INFLAMMATION, RASH, AND ITCHING AT THE SITE WHERE THE DERMABOND WAS APPLIED. THE PATIENT WAS SENT HOME ON PREDNISONE DOSE PACK AND KEFLEX. DURING A FOLLOW UP CALL IN 2008, THE CUSTOMER STATED THAT NO ADDITIONAL INFORMATION COULD BE PROVIDED AT THE TIME. THE PATIENT WAS FROM A DIFFERENT PRACTICE. THE CUSTOMER ADVISED THAT THE INTENT FOR THE CALL WAS TO GET DIRECTIONS ON HOW TO REMOVE EXCESS DEVICE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WITH THE OTHER PRACTICE WERE UNSUCCESSFUL.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other