BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLIDENT DENTURE CLEANSER

    MDR report key: 8183080 · Received December 19, 2018

    Report

    Report Number
    1020379-2018-00075
    Event Type
    Injury
    Date Received
    December 19, 2018
    Report Date
    December 12, 2018
    Manufacturer
    BLOCK DRUG CO., INC.
    Product Code
    EFT
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MFR #: 1020379-2018-00075 IS ASSOCIATED WITH (B)(4), POLIDENT DENTURE CLEANSER.

    Description of Event or Problem · 1

    ACCIDENTAL INGESTION [ACCIDENTAL DEVICE INGESTION]: CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER VIA CALL CENTER REPRESENTATIVE AND DESCRIBED THE OCCURRENCE OF ACCIDENTAL DEVICE INGESTION IN A FEMALE PATIENT WHO RECEIVED DENTURE CLEANSER (POLIDENT DENTURE CLEANSER) UNKNOWN FOR PRODUCT USED FOR UNKNOWN INDICATION. ON AN UNKNOWN DATE, THE PATIENT STARTED POLIDENT DENTURE CLEANSER. ON AN UNKNOWN DATE, AN UNKNOWN TIME AFTER STARTING POLIDENT DENTURE CLEANSER, THE PATIENT EXPERIENCED ACCIDENTAL DEVICE INGESTION (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT). THE ACTION TAKEN WITH POLIDENT DENTURE CLEANSER WAS UNKNOWN. ON AN UNKNOWN DATE, THE OUTCOME OF THE ACCIDENTAL DEVICE INGESTION WAS NOT REPORTED. THE REPORTER CONSIDERED THE ACCIDENTAL DEVICE INGESTION TO BE RELATED TO POLIDENT DENTURE CLEANSER. THIS REPORT IS MADE BY GSK WITHOUT PREJUDICE AND DOES NOT IMPLY ANY ADMISSION OR LIABILITY FOR THE INCIDENT OR ITS CONSEQUENCES. ADDITIONAL DETAILS: THE CONSUMER REPORTED THAT SHE SWALLOWED THE SOLUTION BY ACCIDENT AND READ IN THE BOX TO CALL POISON CONTROL IN CASE YOU SWALLOW IT. SHE DID NOT HAVE THE PHONE NUMBER FOR POISON CONTROL AND DID NOT HAVE A DOCTOR TO SEE. AGE NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1017662 POLIDENT DENTURE CLEANSER DENTURE CLEANSER EFT BLOCK DRUG CO., INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other