BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATTERSON SALIVA EJECTORS

    MDR report key: 10706650 · Received October 20, 2020

    Report

    Report Number
    9611959-2020-00002
    Event Type
    Malfunction
    Date Received
    October 20, 2020
    Date of Event
    February 14, 2020
    Report Date
    October 20, 2020
    Manufacturer
    PATTERSON DENTAL SUPPLY, INC.
    Product Code
    DYN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO HARM TO THE PATIENT WAS NOTED. AN INVESTIGATION WAS CARRIED OUT BY THE MANUFACTURER, AND A CORRECTIVE ACTION WAS PUT IN PLACE. THE INVESTIGATION CONCLUDED THAT THE CAUSE MAY BE ATTRIBUTED TO THE WELDING DEVICE BEING TEMPORARILY SUSPENDED DURING PRODUCTION. THIS WOULD OCCUR DUE TO THE TRANSITION FROM PRODUCTION OF REMOVABLE CAPS TO PRODUCTION OF SALIVA INJECTOR WITH FIXED CAPS, AND WOULD IMPLY INADEQUATE LINE CLEARANCE.

    Description of Event or Problem · 1

    A PRODUCT COMPLAINT WAS REPORTED TO AMD MEDICOM ON 14-FEB-2020 FOR PATTERSON DENTAL SUPPLY INC. BRAND PRODUCT SALIVA EJECTOR. ITEM CODE 107-3998. THE SALIVA EJECTOR IS CLASSIFIED AS A CLASS 1 MEDICAL DEVICE UNDER FDA CODE DYN. SALIVA EJECTORS 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 "PINK SALIVA EJECTOR (107-3998) AS THE TIP HAS COME OFF MULTIPLE TIMES. " THE COMPLAINT RECEIVED BY AMD MEDICOM HAS BEEN LOGGED AS A PRODUCT QUALITY COMPLAINT UNDER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1171839 PATTERSON SALIVA EJECTORS SALIVA EJECTOR DYN PATTERSON DENTAL SUPPLY, INC. 20190885

    Patients

    Seq Age Sex Outcome Treatment
    1