BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DERMABOND TOPICAL SKIN ADHESIVE

    MDR report key: 7164439 · Received January 4, 2018

    Report

    Report Number
    2210968-2018-70047
    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 Location
    GA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REFERENCE JOURNAL ARTICLE: "TITLE: CONTACT DERMATITIS FROM DERMABOND¿; CITATION: PLASTIC AND RECONSTRUCTIVE SURGERY, JUNE 2010: 125(6):252E-253E. HTTP://JOURNALS.LWW.COM/PLASRECONSURG/FULLTEXT/2010/06000/CONTACT_DERMATITIS_FROM_DERMABOND.58.ASPX.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE THAT A PATIENT UNDERWENT A SCAR REVISION PROCEDURE OF AN ABDOMINOPLASTY ON AN UNKNOWN DATE AND TOPICAL SKIN ADHESIVE WAS USED. THE PATIENT PRESENTED ON POST OPERATIVE DAY 7 WITH PRURITIC ERYTHEMA EXTENDING ALONG THE SURGICAL SCARS BILATERALLY. THE TOPICAL SKIN ADHESIVE WAS REMOVED AND THE RASH WAS TREATED WITH TOPICAL STEROIDS. HER SYMPTOMS DISSIPATED WITHIN SEVERAL DAYS. THREE WEEKS AFTER RESOLUTION OF THE ERYTHEMA, THE PATIENT UNDERWENT A TEST PATCH APPLICATION OF THE TOPICAL SKIN ADHESIVE TO HER LEFT FOREARM THAT RESULTED IN A LOCALIZED ERYTHEMATOUS PRURITIC REACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8094 DERMABOND TOPICAL SKIN ADHESIVE TOPICAL SKIN ADHESIVE MPN ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention