BEUDAMED
    FDA Adverse Event Other Summary report: N

    DERMABOND TOPICAL SKIN ADHESIVE

    MDR report key: 1082546 · Received July 22, 2008

    Report

    Report Number
    1034548-2008-00018
    Event Type
    Other
    Date Received
    July 22, 2008
    Date of Event
    June 5, 2008
    Report Date
    June 23, 2008
    Manufacturer
    CLOSURE MEDICAL CORP.
    Product Code
    MPN
    PMA / PMN Number
    960052
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 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 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 PATIENT REPORTED THAT SHE HAD A VEIN LIGATION - STRIPPING ON HER RIGHT LEG IN 2008. ONE WEEK AFTER THE PROCEDURE, SHE DEVELOPED SEVERE REDDENING OF HER LEG AND TWO WEEKS POST SURGERY 3 SURGICAL SITES OPENED. PATIENT WAS PRESCRIBED KEFLEX FOR 10 DAYS. DURING A FOLLOW UP THE FOLLOWING MONTH, THE SURGEON'S OFFICE REPORTED THAT THE PATIENT HAD REDNESS AROUND THE INCISION SITES OF THE DERMABOND APPLICATION, THE SAME REDNESS WAS SEEN ON THE CONTRALATERAL LEG IN THE SAME PATTERN AS THE OPERATIVE LEG AFTER THE PATIENT LEGS WERE TOGETHER DURING NIGHT SLEEP. NO INTERVENTION WAS PROVIDED FOR THE REDNESS. MONOCRYL SUTURE WAS USED TO CLOSE THE INCISION SITES FOLLOWED BY THE APPLICATION OF DERMABOND. THE PATIENT WOUND DEHISCED AT AN UNSPECIFIED TIME FOLLOWING SURGERY; THE WOUND SITES WERE CULTURED AND GREW GRAM-NEGATIVE RODS. ANTIBIOTICS WERE PRESCRIBED. A SINGLE SUTURE STRAND WAS USED TO ACCOMPLISH CLOSURE OF THE MULTIPLE INCISION SITES. THE SITES WERE ALLOWED TO HEAL BY SECONDARY INTENTION. THE PATIENT WAS REPORTED AS FINE. DURING A FOLLOW UP EIGHT DAYS LATER THE DR. STATED THAT THE INFECTION WAS A POST DEHISCENCE EVENT RELATED TO ENVIRONMENTAL CONTAMINATION. THIS REPORT ACCOUNTS FOR THE TISSUE REACTION PORTION OF THE EVENT.

    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