BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATTERSON SALIVA EJECTORS

    MDR report key: 9293334 · Received November 7, 2019

    Report

    Report Number
    9611959-2019-00002
    Event Type
    Malfunction
    Date Received
    November 7, 2019
    Date of Event
    September 24, 2019
    Report Date
    November 4, 2019
    Manufacturer
    PATTERSON DENTAL SUPPLY INC.
    Product Code
    DYN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    A PRELIMINARY INVESTIGATION WAS PERFORMED BY THE MANUFACTURER ON THE RETAINED LOT. THE RETAINED LOT CONFORMS TO SPECIFICATIONS. NO ROOT CAUSE HAS BEEN IDENTIFIED.

    Description of Event or Problem · 1

    A PRODUCT COMPLAINT ((B)(4)) WAS REPORTED TO AMD MEDICOM ON (B)(6) 2019 FOR PATTERSON DENTAL SUPPLY INC. BRAND PRODUCT SALIVA EJECTOR. ITEM CODE 107-3980, LOT NUMBER 20190287V-S4. THE SALIVA EJECTOR IS CLASSIFIED AS CLASS I MEDICAL DEVICE UNDER FDA CODE DYN. SALIVA ELECTORS ARE USED IN DENTISTRY IN ORDER TO REMOVE SALIVA, BLOOD OR OTHER DEBRIS FROM THE MOUTH DURING DENTAL PROCEDURES. THIS DISPOSABLE DEVICE IS CONNECTED TO AN ACTIVE DEVICE, NORMALLY A PNEUMATIC SYSTEM SUCTION CIRCUIT. THE FOLLOWING INFORMATION WAS INITIALLY REPORTED: "THE TIP/HEAD OF THE SALIVA EJECTOR CAME OFF IN PATIENT'S MOUTH. THIS HAPPENED TO SEVERAL PATIENTS. CHOKING HAZARD".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1083375 PATTERSON SALIVA EJECTORS SALIVA EJECTOR DYN PATTERSON DENTAL SUPPLY INC. 20190287V-S4

    Patients

    Seq Age Sex Outcome Treatment
    1