BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOTENE

    MDR report key: 7952074 · Received October 10, 2018

    Report

    Report Number
    3012293198-2018-00013
    Event Type
    Injury
    Date Received
    October 10, 2018
    Report Date
    October 3, 2018
    Manufacturer
    ULTRADENT PRODUCTS INC/ORATECH LLC
    Product Code
    LFD
    PMA / PMN Number
    K123731
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REPORT # 3012293198-2018-00013 IS ASSOCIATED WITH (B)(4), BIOTENE.

    Description of Event or Problem · 1

    CANCER [LUNG CANCER]. FLUID ON HER LUNG [PLEURAL EFFUSION]. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER VIA INTERACTIVE DIGITAL MEDIA AND DESCRIBED THE OCCURRENCE OF LUNG CANCER IN A FEMALE PATIENT WHO RECEIVED BIOTENE ORAL BALANCE UNKNOWN FORMULATION (BIOTENE) UNKNOWN FOR PRODUCT USED FOR UNKNOWN INDICATION. ON AN UNKNOWN DATE, THE PATIENT STARTED BIOTENE. ON AN UNKNOWN DATE, AN UNKNOWN TIME AFTER STARTING BIOTENE, THE PATIENT EXPERIENCED LUNG CANCER (SERIOUS CRITERIA HOSPITALIZATION AND GSK MEDICALLY SIGNIFICANT) AND PLEURAL EFFUSION. THE ACTION TAKEN WITH BIOTENE WAS UNKNOWN. ON AN UNKNOWN DATE, THE OUTCOME OF THE LUNG CANCER AND PLEURAL EFFUSION WERE UNKNOWN. THE REPORTER CONSIDERED THE LUNG CANCER AND PLEURAL EFFUSION TO BE RELATED TO BIOTENE. ADDITIONAL DETAILS: ADVERSE EVENT REPORTED BY THE DAUGHTER OF PATIENT. THE REPORTER STATED THAT HER MAM TOOK IT REGULAR FROM DOCTOR AND CHEMIST FOR A FEW YEARS SHE WAS RUSHED TO HOSPITAL WITH FLUID ON HER LUNG WHICH WAS CANCER. IT WAS ALWAYS SAID TAKING THIS DAY AFTER DAY WAS A PART OF IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    792470 BIOTENE UNKNOWN LFD ULTRADENT PRODUCTS INC/ORATECH LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O