BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMFORT PLUS PREMIUM SALIVA EJECTORS

    MDR report key: 10532477 · Received September 14, 2020

    Report

    Report Number
    2433773-2020-00004
    Event Type
    Malfunction
    Date Received
    September 14, 2020
    Date of Event
    August 18, 2020
    Report Date
    September 14, 2020
    Manufacturer
    CROSSTEX INTERNATIONAL INC.
    Product Code
    DYN
    UDI-DI
    50732224000676
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY REPORTED A SALIVA EJECTOR TIP DETACHED FROM THE COMFORT PLUS PREMIUM SALIVA EJECTOR TUBE DURING A DENTAL PROCEDURE. THE TIP WAS NOT SWALLOWED BY THE PATIENT. THE PATIENT WAS UNDER LOCAL ANESTHETIC DURING THE PROCEDURE WHEN THE SALIVA EJECTOR TIP WAS DETACHED. IT WAS REPORTED THE DENTIST PERFORMING THE PROCEDURE WAS ABLE TO RETRIEVE THE SALIVA EJECTOR TIP FROM THE PATIENTS MOUTH BEFORE IT WAS SWALLOWED. THE REPORTED EVENT DID NOT CAUSE OR CONTRIBUTE ANY SERIOUS INJURY OR DETERIORATION OF HEALTH. THIS EVENT COULD POTENTIALLY LEAD TO SERIOUS INJURY IF IT WERE TO RECUR. THIS COMPLAINT WILL BE MONITORED IN THE CROSSTEX COMPLAINT HANDLING SYSTEM.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED A SALIVA EJECTOR TIP DETACHED FROM THE COMFORT PLUS PREMIUM SALIVA EJECTOR TUBE DURING A DENTAL PROCEDURE. THE TIP WAS NOT SWALLOWED BY THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    994979 COMFORT PLUS PREMIUM SALIVA EJECTORS SALIVA EJECTORS DYN CROSSTEX INTERNATIONAL INC. ZCB 50732224000676

    Patients

    Seq Age Sex Outcome Treatment
    1