BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLIDENT DENTURE CLEANSER

    MDR report key: 9949024 · Received April 10, 2020

    Report

    Report Number
    3005372036-2020-00001
    Event Type
    Injury
    Date Received
    April 10, 2020
    Report Date
    March 13, 2020
    Manufacturer
    PHARMATECH AS PTI ROYSTON LLC
    Product Code
    EFT
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ARGUS CASE (B)(4).

    Description of Event or Problem · 0

    BRONCHITIS [BRONCHITIS]. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER VIA CALL CENTER REPRESENTATIVE AND DESCRIBED THE OCCURRENCE OF BRONCHITIS IN A MALE PATIENT WHO RECEIVED DENTURE CLEANSER (POLIDENT DENTURE CLEANSER) TABLET (BATCH NUMBER 18G204RGC, EXPIRY DATE 30TH JUNE 2021) AND (BATCH NUMBER P19031601, EXPIRY DATE 30TH JUNE 2021) FOR PRODUCT USED FOR UNKNOWN INDICATION. THIS CASE WAS ASSOCIATED WITH A PRODUCT COMPLAINT. ON AN UNKNOWN DATE, THE PATIENT STARTED POLIDENT DENTURE CLEANSER AT AN UNKNOWN DOSE AND FREQUENCY. ON AN UNKNOWN DATE, THE DOSE WAS CHANGED TO AN UNKNOWN DOSE AND FREQUENCY. ON AN UNKNOWN DATE, AN UNKNOWN TIME AFTER STARTING POLIDENT DENTURE CLEANSER, THE PATIENT EXPERIENCED BRONCHITIS (SERIOUS CRITERIA HOSPITALIZATION) AND PRODUCT COMPLAINT. THE ACTION TAKEN WITH POLIDENT DENTURE CLEANSER WAS UNKNOWN. ON AN UNKNOWN DATE, THE OUTCOME OF THE BRONCHITIS AND PRODUCT COMPLAINT WERE UNKNOWN. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE BRONCHITIS TO BE RELATED TO POLIDENT DENTURE CLEANSER. ADDITIONAL DETAILS, INITIAL AND FOLLOW 1, 2 AND 3 WERE PROCESSED TOGETHER. CONSUMER CALLED TO FOLLOW UP PQC CASE- (B)(4) SAMPLE TEST RESULTS INDICATED THAT HE MAY BE HOSPITALIZED FOR MORE THAN TEN DAYS DUE TO BRONCHITIS NEXT MONDAY ((B)(6)), AND FOLLOW-UP RESULTS CAN CALL HIS SON. SUBSEQUENTLY, CONSUMER SAID THAT HE ALWAYS BOUGHT A BOX OF POLIDENT DENTURE CLEANSER TABLETS EVERY YEAR. BECAUSE POLIDENT DENTURE CLEANSER FOR FULL TABLETS BOUGHT THIS YEAR(30 PIECES) THE PACKAGING AND CLEANSER TABLETS ARE NOT THE SAME AS BEFORE AND THEN THIS BOX OF POLIDENT DENTURE CLEANSER FOR FULL TABLETS HAD BEEN MAILED TO OUR COMPANY FOR TESTING, AND NO SUBSEQUENT PURCHASE AND USE OF POLIDENT CLEANSER TABLETS. 18G204RGC IS THE PRIMARY PACKAGE LOT NUMBER AND P19031601 IS THE SECONDARY PACKAGE LOT NUMBER. THE FOLLOW UP INFORMATION WAS RECEIVED FROM QA DEPARTMENT ON 16 MAR 2020. THE COMPLAINT REMAINS UNCONFIRMED. IT IS NOT KNOWN HOW THE PRODUCT IS HANDLED OR STORED ONCE IT SHIPS FROM THE PTI FACILITY. PRODUCT MEET ALL SPECIFICATION AT THE TIME OF RELEASE. THE FOLLOW UP INFORMATION WAS RECEIVED FROM QA DEPARTMENT ON 17 MAR 2020. CONSUMER PLACED A TABLET IN THE WARM WATER BUT ONLY LITTLE BUBBLES CAME OUT( ON THE SURFACE OF WATER, THE SOLUTION ALSO DIDN'T CHANGE TO GREEN AS USUAL. USED ONE TABLET AFTER BOUGHT ON (B)(6). EFFERVESCENCE IS REDUCED A LOT, ONLY A LITTLE BIT BUBBLE. CONFIRM THAT THERE IS NO ABNORMALITY IN THE PRODUCTION PROCESS, THE PRODUCT IS QUALIFIED FOR RELEASE, AND THERE IS NO ABNORMALITY IN THE SAMPLE INSPECTION. THE COMPLAINT CONCLUSION WILL BE UNSUBSTANTIATED. THE FOLLOW UP INFORMATION WAS RECEIVED ON 17 MAR 2020. THE CONSUMER SAID THAT HE IS STILL HOSPITALIZED. THIS REPORT IS RESUBMITTED TO CAPTURE CORRECTION AND THE INFORMATION WAS RECEIVED ON 13 MAR 2020. THE MANUFACTURER FOR SUSPECT PRODUCT WAS CAPTURED CORRECTLY WITH PHARMA TECH IND. (INITIALLY IT WAS WRONGLY REPORTED AS PTI NOT BLOCK DRUG) AND THE PQC INFORMATION WAS CAPTURED CORRECTLY IN M/W INFO SECTION. THE FOLLOW UP INFORMATION WAS RECEIVED ON 08 APR 2020. CONSUMER STATED THAT HE HAS DISCHARGED FOR 2 DAYS.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    BRONCHITIS [BRONCHITIS], PRODUCT COMPLAINT [PRODUCT COMPLAINT]. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER VIA CALL CENTER REPRESENTATIVE AND DESCRIBED THE OCCURRENCE OF BRONCHITIS IN A MALE PATIENT WHO RECEIVED DENTURE CLEANSER (POLIDENT DENTURE CLEANSER) TABLET (BATCH NUMBER 18G204RGC, EXPIRY DATE 30TH JUNE 2021) AND (BATCH NUMBER P19031601, EXPIRY DATE 30TH JUNE 2021) FOR PRODUCT USED FOR UNKNOWN INDICATION. THIS CASE WAS ASSOCIATED WITH A PRODUCT COMPLAINT. ON AN UNKNOWN DATE, THE PATIENT STARTED POLIDENT DENTURE CLEANSER AT AN UNKNOWN DOSE AND FREQUENCY. ON AN UNKNOWN DATE, THE DOSE WAS CHANGED TO AN UNKNOWN DOSE AND FREQUENCY. ON AN UNKNOWN DATE, AN UNKNOWN TIME AFTER STARTING POLIDENT DENTURE CLEANSER, THE PATIENT EXPERIENCED BRONCHITIS (SERIOUS CRITERIA HOSPITALIZATION) AND PRODUCT COMPLAINT. THE ACTION TAKEN WITH POLIDENT DENTURE CLEANSER WAS UNKNOWN. ON AN UNKNOWN DATE, THE OUTCOME OF THE BRONCHITIS AND PRODUCT COMPLAINT WERE UNKNOWN. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE BRONCHITIS TO BE RELATED TO POLIDENT DENTURE CLEANSER. ADDITIONAL DETAILS, INITIAL AND FOLLOW 1, 2 AND 3 WERE PROCESSED TOGETHER. CONSUMER CALLED TO FOLLOW UP PQC CASE- (B)(6) SAMPLE TEST RESULTS INDICATED THAT HE MAY BE HOSPITALIZED FOR MORE THAN TEN DAYS DUE TO BRONCHITIS NEXT MONDAY ((B)(6)), AND FOLLOW-UP RESULTS CAN CALL HIS SON. SUBSEQUENTLY, CONSUMER SAID THAT HE ALWAYS BOUGHT A BOX OF POLIDENT DENTURE CLEANSER TABLETS EVERY YEAR. BECAUSE POLIDENT DENTURE CLEANSER FOR FULL TABLETS BOUGHT THIS YEAR(30 PIECES) THE PACKAGING AND CLEANSER TABLETS ARE NOT THE SAME AS BEFORE AND THEN THIS BOX OF POLIDENT DENTURE CLEANSER FOR FULL TABLETS HAD BEEN MAILED TO OUR COMPANY FOR TESTING, AND NO SUBSEQUENT PURCHASE AND USE OF POLIDENT CLEANSER TABLETS. 18G204RGC IS THE PRIMARY PACKAGE LOT NUMBER AND P19031601 IS THE SECONDARY PACKAGE LOT NUMBER. THE FOLLOW UP INFORMATION WAS RECEIVED FROM QA DEPARTMENT ON 16 MAR 2020. THE COMPLAINT REMAINS UNCONFIRMED. IT IS NOT KNOWN HOW THE PRODUCT IS HANDLED OR STORED ONCE IT SHIPS FROM THE PTI FACILITY. PRODUCT MEET ALL SPECIFICATION AT THE TIME OF RELEASE. THE FOLLOW UP INFORMATION WAS RECEIVED FROM QA DEPARTMENT ON 17 MAR 2020. CONSUMER PLACED A TABLET IN THE WARM WATER BUT ONLY LITTLE BUBBLES CAME OUT (ON THE SURFACE OF WATER, THE SOLUTION ALSO DIDN'T CHANGE TO GREEN AS USUAL. USED ONE TABLET AFTER BOUGHT ON (B)(6) EFFERVESCENCE IS REDUCED A LOT, ONLY A LITTLE BIT BUBBLE. CONFIRM THAT THERE IS NO ABNORMALITY IN THE PRODUCTION PROCESS, THE PRODUCT IS QUALIFIED FOR RELEASE, AND THERE IS NO ABNORMALITY IN THE SAMPLE INSPECTION. THE COMPLAINT CONCLUSION WILL BE UNSUBSTANTIATED. THE FOLLOW UP INFORMATION WAS RECEIVED ON 17 MAR 2020. THE CONSUMER SAID THAT HE IS STILL HOSPITALIZED. THIS REPORT IS RESUBMITTED TO CAPTURE CORRECTION AND THE INFORMATION WAS RECEIVED ON 13 MAR 2020. THE MANUFACTURER FOR SUSPECT PRODUCT WAS CAPTURED CORRECTLY WITH PHARMA TECH IND. (INITIALLY IT WAS WRONGLY REPORTED AS PTI NOT BLOCK DRUG) AND THE PQC INFORMATION WAS CAPTURED CORRECTLY IN M/W INFO SECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414054 POLIDENT DENTURE CLEANSER DENTURE CLEANSER EFT PHARMATECH AS PTI ROYSTON LLC 18G204RGC

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization