BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DERMABOND ADVANCED UNKNOWN PRODUCT

    MDR report key: 8075730 · Received November 15, 2018

    Report

    Report Number
    2210968-2018-77186
    Event Type
    Injury
    Date Received
    November 15, 2018
    Report Date
    October 26, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    MPN
    PMA / PMN Number
    K100423
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS RELATED TO A JOURNAL ARTICLE, THEREFORE NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: DOES THE SURGEON BELIEVE THAT THE DERMABOND PRODUCT INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POSTOPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE?-YES. THE DOCTOR COMMENTED ""IN THESE PATIENTS, WE CONSIDERED THAT SENSITIZATION TO DBA HAD BEEN OCCURRED WITH THE FIRST USE OF DBA."" IN THE ARTICLE DISCUSSION. DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE DERMABOND PRODUCT USED IN THIS PROCEDURE?-NO INFORMATION." CITATION: PLAST RECONSTR SURG GLOB OPEN. 2018; 6: E1841. DOI: 10.1097/GOX.0000000000001841 (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE "TITLE: CONTACT DERMATITIS CAUSED BY DERMABOND ADVANCED USE" AUTHORS: SHIHO NAKAGAWA, MD; HIROKAZU UDA, MD; SHUNJI SARUKAWA, MD; ATARU SUNAGA, MD; RINTARO ASAHI, MD; DAEKWAN CHI, MD; KOTARO YOSHIMURA, MD CITATION: PLAST RECONSTR SURG GLOB OPEN. 2018; 6: E1841. DOI: 10.1097/GOX.0000000000001841 DERMABOND ADVANCED (ETHICON) IS A LIQUID SKIN ADHESIVE AGENT CONTAINING 2-OCTYL-CYANOACRYLATE. IT HAS BEEN WIDELY USED GLOBALLY AND HAS MANY ADVANTAGES. IN THIS STUDY, THE AUTHORS INVESTIGATED THE CHARACTERIZATION OF CONTACT DERMATITIS AFTER DERMABOND USE AND EXAMINED ITS INCIDENCE RATE FROM THE CLINICAL EXPERIENCES TO CLARIFY THE ADEQUATE USE OF DERMABOND. BASED ON THESE RESULTS, THE AUTHORS ALSO EVALUATED THE SAFE USE OF DERMABOND IN THE CLINICAL SETTING. THE AUTHORS CONDUCTED A RETROSPECTIVE REVIEW OF 100 CONSECUTIVE PATIENTS (AGE RANGE: 30 TO 72 YEARS OLD) WHO UNDERWENT SKIN CLOSURE WITH DERMABOND AT JICHI MEDICAL UNIVERSITY HOSPITAL BETWEEN JUNE 2012 AND DECEMBER 2015. ALL PATIENTS UNDERWENT BREAST RECONSTRUCTION SURGERY, AND DERMABOND (ETHICON) WAS MAINLY USED ON THEIR TRUNKS, SUCH AS, FOR ABDOMINAL WOUND CLOSURE AFTER ABDOMINAL FLAP ELEVATION. REPORTED COMPLICATIONS INCLUDED PATIENT 1, A (B)(6) WOMAN WITH CONTACT DERMATITIS AND LONG LASTING SKIN PIGMENTATION WHICH WAS TREATED WITH STEROID OINTMENT; PATIENT 2, A (B)(6) WOMAN WITH SEVERE CONTACT DERMATITIS WHICH WAS TREATED WITH STEROID OINTMENT; PATIENT 3, A (B)(6) WOMAN WITH CONTACT DERMATITIS WITH SEVERE BLISTERS AND SKIN REDNESS WHICH WAS TREATED WITH STEROID OINTMENT; PATIENT 4, A (B)(6) PATIENT WITH CONTACT DERMATITIS WHICH WAS TREATED WITH STEROID OINTMENT; PATIENT 5, A (B)(6) PATIENT WITH CONTACT DERMATITIS WHICH WAS TREATED WITH STEROID OINTMENT; PATIENT 6, A (B)(6) PATIENT WITH CONTACT DERMATITIS WHICH WAS TREATED WITH STEROID OINTMENT; AND PATIENT 7, A (B)(6) PATIENT WITH CONTACT DERMATITIS WHICH WAS TREATED WITH STEROID OINTMENT. THE AUTHORS CONSIDERED THAT DERMABOND USE IS INADEQUATE FOR WOUNDS WITH AN IMPROPER MARGIN AND IN DRY AND LOW-SKIN BARRIER AREAS SUCH AS THE TRUNK AND LIMBS BECAUSE IT MAY INDUCE IRRITANT CONTACT DERMATITIS AND SENSITIZATION OF DERMABOND AND SUBSEQUENT ALLERGIC CONTACT DERMATITIS. FREQUENT USE CAN ALSO INDUCE SENSITIZATION. IF PATIENTS HAVE A HISTORY OF ACRYLATE ALLERGIES, DERMABOND USE SHOULD BE AVOIDED BECAUSE IMMUNOLOGICAL CROSS-REACTION FROM ACETYLATES COULD RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    913603 DERMABOND ADVANCED UNKNOWN PRODUCT ADHESIVE, TOPICAL SKIN MPN ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention