BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAIN AWAY PLUS DENTURE CLEANER

    MDR report key: 6399033 · Received March 9, 2017

    Report

    Report Number
    MW5068399
    Event Type
    Injury
    Date Received
    March 9, 2017
    Date of Event
    March 7, 2017
    Report Date
    March 8, 2017
    Manufacturer
    REGENT LABS, INC.
    Product Code
    EFT
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I PURCHASED STAIN AWAY PLUS DENTURE CLEANER FOR THE FIRST TIME BECAUSE I HAD NEVER SEEN IT BEFORE. I HAVE AN UPPER DENTURE AND A BOTTOM PARTIAL. I SOAKED 15 MINUTES, AS SUGGESTED BECAUSE MY PARTIAL HAD METAL IN IT. WHEN TIME WAS UP I SET THE CUP UNDER RUNNING WATER WHILE I WASHED MY FACE AND BRUSHED MY OWN TEETH. I REMOVED THEM FROM THE CUP AND CONTINUED TO RINSE THEM. WHEN I PUT THEM IN MY MOUTH I DIDN'T LIKE HOW THEY FELT. SO I TOOK THEM OUT AND BRUSHED THEM WITH A TOOTHBRUSH AND TOOTH PASTE. EVEN THOUGH IT IS NOT USUAL I SLEPT WITHOUT MY DENTURES THAT NIGHT. I JUST DIDN'T FEEL COMFORTABLE. THE NEXT MORNING I AWOKE TO A SORE MOUTH. WHEN I LOOKED IN THE MIRROR MY BOTTOM LIP WAS DEEP, DARK RED AND SWOLLEN TWICE ITS SIZE. THERE WERE SMALL BLISTERS ALL INSIDE MY LOWER LIP AND COVERED AREAS INSIDE OF MY MOUTH, ESPECIALLY THE ROOT OF MY MOUTH. I CAN NOT EAT OR EVEN DRINK ANYTHING EXCEPT COLD WATER. I AM RINSING WITH SALT WATER AND SOAKING THE DENTURES IN BAKING SODA AND WATER IN AN EFFORT TO REMOVE ANY LEFTOVER RESIDUE. I AM IN CONSTANT PAIN AND DISCOMFORT. IS THE PRODUCT OVER-THE-COUNTER: YES. FREQUENCY: OTHER - AS NEEDED. HOW WAS IT TAKEN OR USED: OTHER - SOAK DENTURES IN. DATE THE PERSON FIRST STARTED TAKING OR USING THE PRODUCT: (B)(6) 2017. DATE THE PERSON STOPPED TAKING OR USING THE PRODUCT: (B)(6) 2017. WHY WAS THE PERSON USING THE PRODUCT: THIS WAS JUST TO CLEAN MY DENTURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175247 STAIN AWAY PLUS DENTURE CLEANER STAIN AWAY PLUS DENTURE CLEANER EFT REGENT LABS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Disability JANUVIA| LANTOS SOLOSTAR| NORCO| OTC MEDS: VITAMIN D| POTASSIUM| RX MEDS: ATENOLOL| TRAZODONE| TYLENOL| ZOLOFT