BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUNMED

    MDR report key: 9253995 · Received October 29, 2019

    Report

    Report Number
    2183650-2019-00001
    Event Type
    Malfunction
    Date Received
    October 29, 2019
    Date of Event
    September 10, 2019
    Report Date
    October 15, 2019
    Manufacturer
    MEDITEC DEVICES
    Product Code
    BSR
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    AL, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER SAYS THE TIP BROKE OFF THE PRODUCT. NO OTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1047838 SUNMED ET INTRODUCER 9-0212-70 BSR MEDITEC DEVICES MD 163

    Patients

    Seq Age Sex Outcome Treatment
    1