BEUDAMED
    FDA Adverse Event Other Summary report: N

    DERMABOND (R) TOPICAL SKIN ADHESIVE

    MDR report key: 730871 · Received June 26, 2006

    Report

    Report Number
    1034548-2006-00006
    Event Type
    Other
    Date Received
    June 26, 2006
    Date of Event
    April 19, 2006
    Report Date
    April 25, 2006
    Manufacturer
    CLOSURE MEDICAL CORP.
    Product Code
    MPN
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SOME INFO FOR THIS REPORT HAS 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 DOES INDICATE A POSSIBLE SENSITIVITY REACTION TO CYANOACRYLATES OR ITS DERIVATIVES. THE PACKAGE INSERT PROVIDES CONTRAINDICATIONS AND ADVERSE REACTIONS: 1) DO NOT USE ON PTS WITH A KNOWN HYPERSENSITIVITY TO CYANOACRYLATES OR FORMALDEHYDE. 2) REACTIONS MAY OCCUR IN PTS WHO ARE HYPERSENSITIVE TO CYANOACRYLATES OR FORMALDEHYDE.

    Description of Event or Problem · 1

    DEVICE WAS APPLIED TO 2 INCISIONS (FOREHEAD AND FACE) FOLLOWING THE REMOVAL OF 2 SQUAMOUS CELL CARCINAOMA. THE DAY AFTER THE PRODUCT WAS USED THE PT STARTED TO EXPERIENCE PAIN, A BURNING SENSATION, AND REDNESS. THE PT BEGAN A REGIMEN OF VICODEN EVER Y4 HOURS IMMEDIATELY POST-OP, SHE REPORTS HAVING A BURNING SENSATION BEGINNING POST SURGERY. THE PAIN BECAME UNBEARABLE AND THE PT CALLED THE PHYSICIAN ON CALL, HE REPORTEDLY SUSPECTED POST-SURGICAL CELLULITIES. THE PT WAS GIVEN ZITHROMAX. THE PT STATES SHE IS ALLERGIC ADHESIVE TAPE AND CAN ONLY USE PAPER TAPE, SHE HAS REDNESS ONCE TAPE IS REMOVED. THE PT HAD A FEVER OF 100 DEGREES ON 4/23/2006. HER SURGEON SAW HER ON 4/26/2006 AND THE WOUNDS WERE REPORTED AS WELL HEALED, PT CONTINUED TO HAVE A BURNING SENSATION, PT SUSPECTS NERVE DAMAGE FROM SURGERY. THE PT WAS NOT TESTED FOR ALLERGY, CLAIMS SHE HAS NEVER HAD AN ISSUE IN PAST WITH ANY SENSITIVITY TO FORMALIN OR CYANOACRYLATES. THE PT'S CURRENT CONDITION IS UNK. PRODUCT WAS NOT RETURNED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other