BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN BARRX

    MDR report key: 9876144 · Received March 24, 2020

    Report

    Report Number
    3004904811-2020-00005
    Event Type
    Injury
    Date Received
    March 24, 2020
    Date of Event
    September 19, 2017
    Report Date
    March 24, 2020
    Manufacturer
    COVIDIEN LP BARRX
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE: RIAD H. AL NATOUR,1 A. CATANZARO,2 E. ZOLOTAREVSKY,2 ANTHONY T. DEBENEDET,2 NARESH T. GUNARATNAM2 1SURGERY DEPARTMENT, ST JOSEPH MERCY HEALTH SYSTEM, 5333 MCAULEY DRIVE, SUITE RHB-2115, ANN ARBOR, MI 48197, USA AND 2HURON GASTRO CENTER FOR DIGESTIVE DISEASE, ST JOSEPH MERCY HEALTH SYSTEM, 5300 ELLIOTT DR., ANN ARBOR, MI 48197, USA. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    PLI 10: (B)(6) 2014), 60 PATIENTS WITH BIOPSY-PROVEN BARRETT¿S ESOPHAGUS WITH HIGH-GRADE DYSPLASIA (BEHGD) AND INTRAMUCOSAL ESOPHAGEAL ADENOCARCINOMA (IMC), WERE PROSPECTIVELY ENROLLED IN THE STUDY. PATIENTS UNDERWENT ENDOSCOPIC THERAPY FOR BEHGD (32) OR IMC (28). MEDIAN LENGTH BE WAS 4CM. FORTY-SIX PATIENTS HAD ENDOSCOPIC MUCOSAL RESECTION (EMR). RADIO FREQUENCY ABLATION WAS USED TO ABLATE ANY RESIDUAL DYSPLASTIC-BE FOUND DURING SUBSEQUENT ENDOSCOPY SESSIONS. IMMEDIATE POST-EMR BLEEDING REQUIRING ENDOCLIPS AND/OR LOCAL EPINEPHRINE INJECTION OCCURRED IN TWO PATIENTS. THERE WAS NO PROCEDURE-RELATED MORTALITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334139 UNKNOWN BARRX GEI COVIDIEN LP BARRX UNKNOWN BARRX

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention