BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    CS 3600 SINGLE USE NORMAL TIPS

    MDR report key: 11366583 · Received February 23, 2021

    Report

    Report Number
    1317307-2021-00001
    Event Type
    Malfunction
    Date Received
    February 23, 2021
    Date of Event
    January 25, 2021
    Report Date
    February 22, 2021
    Manufacturer
    CARESTREAM DENTAL LLC
    Product Code
    NOF
    UDI-DI
    60192156568748
    PMA / PMN Number
    NONE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    WHEN USING THE CS 3600 ACCESSORY: CS 3600 SINGLE USE NORMAL TIP, THE MIRROR CAN BE DETACHED FROM THE UNIT. WHEN THIS EVENT OCCURRED, THE MIRROR FELL FROM THE UNIT INTO THE PATIENT'S MOUTH. THE PATIENT WAS ABLE TO REMOVE THE MIRROR AND THE PATIENT DID NOT SUSTAIN ANY INJURIES. THE SIZE OF THE MIRROR (22MMX13MMX1.5MM) MAKES IT POSSIBLE FOR THE MIRROR TO BE SWALLOWED OR ASPIRATED. IF THE MIRROR IS SWALLOWED OR ASPIRATED, SURGICAL INTERVENTION WOULD BE REQUIRED TO REMOVE THE MIRROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261011 CS 3600 SINGLE USE NORMAL TIPS CS 3600 SINGLE USE NORMAL TIPS NOF CARESTREAM DENTAL LLC CS 3600 2020-06 60192156568748

    Patients

    Seq Age Sex Outcome Treatment
    1