BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHARKCORE

    MDR report key: 10488532 · Received September 3, 2020

    Report

    Report Number
    3004904811-2020-00025
    Event Type
    Injury
    Date Received
    September 3, 2020
    Date of Event
    June 3, 2020
    Report Date
    September 3, 2020
    Manufacturer
    COVIDIEN LP BARRX
    Product Code
    FCG
    UDI-DI
    00855208005131
    PMA / PMN Number
    K141894
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE: COMPARISON OF TWO SPECIALIZED HISTOLOGY NEEDLES FOR ENDOSCOPIC ULTRASOUND (EUS)-GUIDED LIVER BIOPSY: A PILOT STUDY SOURCE: DIGESTIVE DISEASES AND SCIENCES HTTPS://DOI.ORG/10.1007/S10620-020-06391-3, RECEIVED: 22 APRIL 2020 / ACCEPTED: 3 JUNE 2020 SPRINGER SCIENCE+BUSINESS MEDIA, LLC, PART OF SPRINGER NATURE 2020. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE LITERATURE SOURCE OF THE STUDY PERFORMED, FROM OCTOBER, 2018 TO SEPTEMBER 2019. TWO OF THE PATIENTS FORM THE SAME STUDY HAD A BIOPSY USING THE COMPETITORS AND COMPANY'S DEVICE. BOTH PATIENTS REPORTED AN ABDOMINAL PAIN AFTER THE OPERATION AND HAD A CT-SCAN, WHICH SHOWED NO ABNORMAL FINDING. THE PATIENTS STAYED OVERNIGHT FOR OBSERVATION AND WERE DISCHARGED THE NEXT MORNING AFTER THEIR PAIN WAS CONTROLLED BY MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    956296 SHARKCORE KIT, NEEDLE, BIOPSY FCG COVIDIEN LP BARRX DSL-19-01 00855208005131

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R