BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DERMABOND UNKNOWN PRODUCT

    MDR report key: 13635922 · Received March 1, 2022

    Report

    Report Number
    2210968-2022-01406
    Event Type
    Injury
    Date Received
    March 1, 2022
    Date of Event
    January 1, 2020
    Report Date
    March 1, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    MPN
    PMA / PMN Number
    K100423
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). ADDITIONAL INFORMATION: AS NO CONTACT INFORMATION HAS BEEN PROVIDED, NO FOLLOW UP CAN OR WILL BE PERFORMED AT THIS TIME. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. 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. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: THE AMERICAN JOURNAL OF GASTROENTEROLOGY VOLUME 115 / SUPPLEMENT / OCTOBER 2020. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    IT WAS NOTED VIA JOURNAL ARTICLE: TITLE: EXPERIENCE WITH ENDOSCOPIC ULTRASOUND-GUIDED GASTRIC VARICEAL CYANOACRYLATE INJECTION IN A TERTIARY CARE CENTER THIS RETROSPECTIVE ANALYSIS STUDY AIMS TO ANALYZED OUTCOMES OF PATIENTS WHO UNDERWENT ENDOSCOPIC ULTRASOUND (EUS) GUIDED FINE NEEDLE INJECTION (EUS-FNI) OF GASTRIC VARICES (GV) IN A LARGE TERTIARY REFERRAL CENTER. BETWEEN 1/1/2013 TO 11/30/2019 , 81 PATIENTS (47M, MEAN AGE: 58 6 12 YRS.) WHO UNDERWENT ENDOSCOPIC ULTRASOUND (EUS) GUIDED FINE NEEDLE INJECTION (EUS-FNI) WITH 2-OCTYLCYANOACRYLATE (DERMABOND, ETHICON US, LLC) INCLUDING 64 PATIENTS FORGASTRIC VARICES WERE ANALYZED . PATIENTS RETURNED 2¿3 MONTHS AFTER INITIAL FINE NEEDLE INJECTION (FNI) FOR POSSIBLE REPEAT INJECTION IF SIGNIFICANT DOPPLER FLOW REMAINED IN THE VARIX, MINIMAL TO ABSENT FLOW WAS CONSIDERED GASTRIC VARICES (GV) ERADICATION. REPORTED COMPLICATION INCLUDED: (N=6) RECURRENT BLEEDING. (MILD) ADVERSE EVENT 24 POST PROCEDURE : (N=6) ABDOMINAL PAIN , AND (N=1) LOW GRADE FEVER. (MODERATE/SEVERE) ADVERSE EVENT 24 HOURS POST PROCEDURE (N=1) DIFFUSE ALVEOLAR HEMORRHAGE (MILD) 1 TO 30 DAYS POST PROCEDURE: (N=3) ABDOMINAL PAIN AND (N=2) LOW GRADE FEVER. (MODERATE /SEVERE(1-30 DAYS POST PROCEDURE) : (N=1) SPLENIC INFARCTION, (N=1) SEPSIS ,AND (N=1) HIGH GRADE FEVER. IT WAS CONCLUDED, THAT IN THE LARGE SINGLE CENTER COHORT, ULTRASOUND (EUS) GUIDED FINE NEEDLE INJECTION (EUS-FNI) FOR PRIMARY PROPHYLAXIS OR RECENT GV BLEEDING IS FEASIBLE AND OFTEN SUCCESSFUL IN ONE TREATMENT. REBLEEDING OCCURS IN 9.4%. TREATMENT MAY BE ASSOCIATED WITH RARE BUT POTENTIALLY SEVERE ADVERSE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1173001 DERMABOND UNKNOWN PRODUCT ADHESIVE, TOPICAL SKIN MPN ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention