BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLIDENT NEO DENTURE CLENSER

    MDR report key: 11629801 · Received April 7, 2021

    Report

    Report Number
    1020379-2021-00014
    Event Type
    Injury
    Date Received
    April 7, 2021
    Report Date
    March 11, 2021
    Manufacturer
    BLOCK DRUG CO., INC.
    Product Code
    EFT
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    ARGUS CASE ID: (B)(4).

    Description of Event or Problem · 1

    HOSPITALISATION [HOSPITALISATION] CASE DESCRIPTION: THIS CASE WAS REPORTED BY A NON-HEALTH PROFESSIONAL VIA CALL CENTER REPRESENTATIVE AND DESCRIBED THE OCCURRENCE OF HOSPITALISATION IN A FEMALE PATIENT WHO RECEIVED DENTURE CLEANSER (POLIDENT NEO DENTURE CLEANSER) TABLET FOR DENTURE WEARER. CONCURRENT MEDICAL CONDITIONS INCLUDED DENTURE WEARER. ON AN UNKNOWN DATE, THE PATIENT STARTED POLIDENT NEO DENTURE CLEANSER. ON AN UNKNOWN DATE, AN UNKNOWN TIME AFTER STARTING POLIDENT NEO DENTURE CLEANSER, THE PATIENT EXPERIENCED HOSPITALISATION (SERIOUS CRITERIA HOSPITALIZATION) AND DENTURE DISCOLOURATION. THE ACTION TAKEN WITH POLIDENT NEO DENTURE CLEANSER WAS UNKNOWN. ON AN UNKNOWN DATE, THE OUTCOME OF THE HOSPITALISATION AND DENTURE DISCOLOURATION WERE UNKNOWN. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE HOSPITALISATION TO BE RELATED TO POLIDENT NEO DENTURE CLEANSER. [CLINICAL COURSE] ON AN UNKNOWN DATE, POLIDENT NEO DENTURE CLENSER WAS USED, THEN, DEVICE DISCOLOURATION OF THE PINK PART OF THE DENTURES OCCURRED. THE ABOVE WAS MENTIONED BY THE CUSTOMER WHO CURRENTLY APPEARED. THE USER WAS THE CUSTOMER'S WIFE WHO WAS CURRENTLY IN THE HOSPITAL. FOR THE PURPOSE OF PREVENTING COVID-19, THE USER'S FAMILY COULD NOT MEET WITH THE USER WHO WAS THE INPATIENT. THEREFORE, THE DETAILS WERE COMPLETELY UNKNOWN. HEARING FROM THE HOSPITALIZED CUSTOMER'S WIFE (THE USER), THE OBTAINED INFORMATION WAS ONLY AS FOLLOWS: THE DENTURES WERE SOAKED IN POLIDENT NEO DENTURE CLEANSER, THEN, THE DEVICE DISCOLOURATION OF THE PINK PART OF THE DENTURES OCCURRED. THE CUSTOMER WOULD BE CONTACTABLE A LONG WAY AHEAD AFTER THE DISCOVERY OF THE DETAILS OF THE DEVICE DISCOLOURATION FOLLOWING THE CUSTOMER'S WIFE'S (THE USER) DISCHARGE. THE DENTURES WOULD BE CHECKED BY THE DOCTOR, THEREAFTER, THE CONTACT FROM THE CUSTOMER WOULD BE RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523353 POLIDENT NEO DENTURE CLENSER DENTURE CLEANSER EFT BLOCK DRUG CO., INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization