BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DERMABOND TOPICAL SKIN ADHESIVE

    MDR report key: 7165052 · Received January 4, 2018

    Report

    Report Number
    2210968-2018-70054
    Event Type
    Injury
    Date Received
    January 4, 2018
    Report Date
    December 18, 2017
    Manufacturer
    ETHICON INC.
    Product Code
    MPN
    PMA / PMN Number
    K100423
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). TO DATE, THE DEVICE HAS NOT BEEN RETURNED. IF THE PRODUCT IS RETURNED FOR EVALUATION, ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT: HAVE THESE EVENTS BEEN PREVIOUSLY REPORTED TO ETHICON? WHAT IN THE PHYSICIANS OPINION ARE THE FACTORS CONTRIBUTING TO THE EVENT(S)? PLEASE PROVIDE PHOTOS INITIAL PROCEDURE DATE PLEASE PROVIDE PATIENT IDENTIFIERS FOR EACH PATIENT EVENT: INITIALS / ID HOW THE DEVICE WAS USED (WHAT LAYER OF TISSUE AND HOW MANY LAYERS APPLIED)? WHAT PREP WAS USED PRIOR TO, DURING OR AFTER DERMABOND USE? WAS A DRESSING PLACED OVER THE INCISION? IF SO, WHAT TYPE OF COVER DRESSING USED? DO YOU HAVE THE PRODUCT CODE AND LOT NUMBER INVOLVED ? IS THE PATIENT HYPERSENSITIVE OR HAVE ALLERGIES TO CYANOACRYLATE OR FORMALDEHYDE? PATIENT PRE-EXISTING MEDICAL CONDITIONS (IE. ALLERGIES, HISTORY OF REACTIONS) WAS DEMABOND OR SKIN ADHESIVE USED ON THE PATIENT IN A PREVIOUS SURGERY OR WOUND CLOSURE? REFERENCE ATTACHED JOURNAL ARTICLE: CONTACT DERMATITIS 2009: 61: 299¿300.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE (TITLE: CONTACT DERMATITIS AFTER ORTHOPAEDIC SURGERY) THAT THE PATIENT UNDERWENT AN ORTHOPAEDIC SURGERY ON UNKNOWN DATE AND TOPICAL SKIN ADHESIVE WAS USED. THE PATIENT PRESENTED WITH ECZEMATOUS REACTIONS LOCATED AT THE SURGICAL SITES. THE PATIENT COMPLAINED OF PRURITUS AFFECTING THE AREA OF THE OPERATION 2-3 DAYS AFTER THE FIRST SURGICAL INTERVENTION. WHEN THE DRESSINGS WERE REMOVED 1-2 WEEKS LATER, A PAPULO-VESICULAR ERUPTION WAS EVIDENT. ALTHOUGH THERE WAS COMPLETE RESOLUTION WITHIN 15-20 DAYS WITH TOPICAL CORTICOSTEROID, THERE WAS RECURRENCE WITH SUCCESSIVE INTERVENTIONS. PATIENT WAS PATCH TESTED AND SHOWED A POSITIVE REACTION TO TOPICAL SKIN ADHESIVE. THE REACTIONS SHOWN BY THE PATIENT COULD HAVE BEEN THE RESULT OF ACTIVE SENSITIZATION DUE TO THE CONDITIONS OF THE ADHESIVE APPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    6935 DERMABOND TOPICAL SKIN ADHESIVE TOPICAL SKIN ADHESIVE MPN ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention