BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDICOM SAFEBASIC SALIVA EJECTORS

    MDR report key: 10687288 · Received October 15, 2020

    Report

    Report Number
    9611959-2020-00001
    Event Type
    Malfunction
    Date Received
    October 15, 2020
    Date of Event
    December 3, 2019
    Report Date
    October 15, 2020
    Manufacturer
    AMD MEDICOM INC.
    Product Code
    DYN
    UDI-DI
    10686864049231
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION WAS CONDUCTED AT THE MANUFACTURING FACILITY. 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 (B)(6) 2019 FOR MEDICOM SAFEBASICS SALIVA EJECTOR. ITEM CODE 700 LOT# 20181426. THE SALIVA EJECTOR IS CLASSIFIED AS A CLASS 1 MEDICAL DEVICE UNDER FDA CODE DYN. SALIVA EJECTORS ARE USED IN DENTRISTRY 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 BLUE TIPS ARE POPPING OFF IN PEOPLE'S MOUTHS AND THE TIPS ARE EVEN OFF THE SALIVA EJECTORS IN THE BAGS." 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
    1147487 MEDICOM SAFEBASIC SALIVA EJECTORS SALIVA EJECTOR DYN AMD MEDICOM INC. 700 20181426 10686864049231

    Patients

    Seq Age Sex Outcome Treatment
    1