BEUDAMED
    FDA Adverse Event Death Summary report: N

    DERMABOND TOPICAL SKIN ADHESIVE

    MDR report key: 7192469 · Received January 15, 2018

    Report

    Report Number
    2210968-2018-70294
    Event Type
    Death
    Date Received
    January 15, 2018
    Report Date
    January 2, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    MPN
    PMA / PMN Number
    K100423
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (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. REFERENCE JOURNAL ARTICLE "TITLE: OUTCOMES AND PREDICTORS OF REBLEEDING AFTER 2-OCTYL CYANOACRYLATE INJECTION IN ACUTE GASTRIC VARICEAL HEMORRHAGE.¿ HTTP://JOURNALS.LWW.COM/JCGE/ABSTRACT/2016/07000/OUTCOMES_AND_PREDICTORS_OF_REBLEEDING_AFTER.6.ASPX.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE THAT THE PATIENT UNDERWENT A GASTRIC VARICEAL HEMORRHAGE PROCEDURE ON AN UNKNOWN DATE BETWEEN JANUARY 2000 TO JANUARY 2015 AND AN ENDOSCOPIC INJECTION OF 2-OCTYLCYANOACRYLATE (2-OCA) WAS USED ON AN OFF-LABEL BASIS. FOR THE PROCEDURE, THE TOPICAL SKIN ADHESIVE WAS DRAWN INTO 3 ML SYRINGES AND INJECTED UNDILUTED. A SPECIALIZED 21-G INJECTION CATHETER WAS USED TO INJECT THE CYANOACRYLATE INTO THE GASTRIC VARICES. A SERIOUS ADVERSE EVENT OCCURRED AS A RESULT OF THE 2-OCA INJECTION WHICH MANIFESTED AS PULMONARY GLUE EMBOLISM WHICH WAS FATAL. AN AUTOPSY REVEALED SIGNIFICANT EMBOLIC GLUE MATERIAL IN BOTH LUNGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33750 DERMABOND TOPICAL SKIN ADHESIVE TOPICAL SKIN ADHESIVE MPN ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Death