BEUDAMED
    FDA Adverse Event Other Summary report: N

    DERMABOND TOPICAL SKIN ADHESIVE

    MDR report key: 1082553 · Received July 22, 2008

    Report

    Report Number
    1034548-2008-00017
    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

    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 PACKAGE INSERT INDICATES THAT THE ADHESIVE SHOULD NOT BE USED IN AREAS EXPOSED TO PROLONGED MOISTURE OR FRICTION. THE AREA SHOULD BE DRY PRIOR TO APPLYING THE ADHESIVE TO ASSURE DIRECT CONTACT FOR ADHERENCE OF THE ADHESIVE WITH THE SKIN. PACKAGE INSERT ALSO STATES THAT PATIENTS TREATED WITH DERMABOND TOPICAL SKIN ADHESIVE SHOULD BE INSTRUCTED THAT UNTIL THE POLYMERIZED FILM HAS SLOUGHED NATURALLY (USUALLY IN 5-10 DAYS) THERE SHOULD BE ONLY TRANSIENT WETTING OF THE TREATMENT SITE. THE PATIENT MAY SHOWER AND BATHE THE TREATMENT SITE GENTLY. THE SITE SHOULD NOT BE SCRUBBED, SOAKED, OR EXPOSED TO PROLONG WETNESS UNTIL THE FILM HAS SLOUGHED OFF NATURALLY AND THE WOUND HAS HEALED CLOSED.

    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 WOUND DEHISCENCE 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