BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KLEENITE

    MDR report key: 226450 · Received May 28, 1999

    Report

    Report Number
    MW4002530
    Event Type
    Injury
    Date Received
    May 28, 1999
    Date of Event
    May 18, 1999
    Report Date
    May 26, 1999
    Manufacturer
    REGENT LABS, INC.
    Product Code
    EFT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    RPTR STATES THAT THE REFERENCED DENTURE CLEANER CAUSED A PEPPERY/BURNING SENSATION WHEREVER IT TOUCHED HER GUMS. AFTER 2 WEEKS, SHE ALSO BEGAN TO HAVE PROBLEMS WITH BLURRED VISION, INCREASED URINATION, SWELLING OF HER HANDS AND FEET AND HAVING A BAD TASTE IN HER MOUTH. SHE HAS USED THIS PRODUCT MANY TIMES IN THE PAST WITHOUT ANY PROBLEMS. HOWEVER, UNTIL JUST RECENTLY, SHE HAD NOT BEEN ABLE TO FIND THE PRODUCT IN THE STORES FOR 3 TO 4 MONTHS. SHE BEGAN USING A NEW SET OF DENTURES AT ABOUT THE SAME TIME SHE AGAIN BEGAN TO USE THE SUSPECT CLEANER. BUT HER DENTIST TOLD HER THAT HER NEW DENTURES WERE MADE FROM THE SAME MATERIAL AS HER OLD DENTURES. SHE TRIED THE SUSPECT CLEANER ON HER OLD DENTURES AND FOUND SHE EXPERIENCED THE SAME PROBLEMS, HOWEVER THEY WERE NOT AS SEVERE. ON 5/25/99, MFR REP STATED THE PRODUCT IS MANUFACTURED ON A DEDICATED LINE. THEY HAVE REC'D NO SIMILAR COMPLAINTS. THE CODE THE CONSUMER REPORTED IS NOT CORRECT. ON 5/26/99, RPTR STATED THERE ARE NO OTHER NUMBERS ON THE BOTTOM OF THE CONTAINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KLEENITE DENTURE CLEANER POWDER EFT REGENT LABS, INC. 7.5 OZ, PLASTIC 69006

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN