BEUDAMED
    FDA Adverse Event No answer provided Summary report: N

    VIZIGO

    MDR report key: 13117589 · Received December 30, 2021

    Report

    Report Number
    13117589
    Event Type
    No answer provided
    Date Received
    December 30, 2021
    Date of Event
    November 23, 2021
    Report Date
    December 10, 2021
    Manufacturer
    BIOSENSE WEBSTER INC.
    Product Code
    DYB
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING PREPARATION OF THE SHEATH, THE DILATOR WOULD NOT PASS THROUGH THE SHEATH. THE SHEATH WAS REMOVED AND REPLACED WITH A NEW SHEATH. THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2018360 VIZIGO INTRODUCER, CATHETER DYB BIOSENSE WEBSTER INC. D138502 1814

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown