BEUDAMED
    FDA Adverse Event Injury Summary report: N

    450 SAL EJECTOR 3283

    MDR report key: 9967168 · Received April 16, 2020

    Report

    Report Number
    9612030-2020-02451
    Event Type
    Injury
    Date Received
    April 16, 2020
    Date of Event
    April 5, 2020
    Report Date
    April 16, 2020
    Manufacturer
    COVIDIEN
    Product Code
    DYN
    UDI-DI
    10884521020337
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE FOR THIS EVENT. IF ADDITIONAL INFORMATION OR THE SAMPLE IS RECEIVED, THE INVESTIGATION WILL BE REOPENED AND RESPONDED TO ACCORDINGLY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT RIGHT AFTER THEY STARTED USING THE PRODUCT, THE BLUE CAP ON THE TIP DROPPED INTO THE PATIENT'S MOUTH. THE CAP WAS ABLE TO BE REMOVED IMMEDIATELY FROM THE PATIENT'S MOUTH AND THERE WAS NO ADDITIONAL TREATMENT NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433078 450 SAL EJECTOR 3283 MOUTHPIECE, SALIVA EJECTOR DYN COVIDIEN 8881450004 10884521020337

    Patients

    Seq Age Sex Outcome Treatment
    1 Other