BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DENTEMP SOFT-GRIP DENTURE RELINER

    MDR report key: 22461204 · Received July 9, 2025

    Report

    Report Number
    MW5172473
    Event Type
    Injury
    Date Received
    July 9, 2025
    Date of Event
    July 5, 2025
    Report Date
    July 7, 2025
    Manufacturer
    DOC BRANDS, INC.
    Product Code
    EBP
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    PRODUCT: DENTEMP SOF-GRIP ONE-STEP DENTURE RELINER LOT NUMBER: 5353637; EXPIRATION DATE: 2027-08-31. AFTER APPLYING THIS DENTURE RELINER TO MY UPPER DENTURE AS INSTRUCTED, I DEVELOPED IMMEDIATE AND SEVERE SYMPTOMS: PAINFUL SORES ON THE ROOF OF MY MOUTH, INTENSE NAUSEA, DIZZINESS, SWEATING, FATIGUE, AND AN OVERALL FEELING OF BEING EXTREMELY UNWELL. THESE SYMPTOMS LASTED OVER TWO DAYS AND SIGNIFICANTLY IMPACTED MY ABILITY TO WORK AND FUNCTION NORMALLY. I FOLLOWED ALL PRODUCT INSTRUCTIONS EXACTLY. INGREDIENTS LISTED: POLYETHYL METHACRYLATE, ALCOHOL, AND 1,2,3-PROPANETRICARBOXYLIC ACID, 2-(ACETOXY)-1,2,3-TRIBUTYL ESTER. I BELIEVE THIS PRODUCT IS UNSAFE AND NEEDS INVESTIGATION. I EXPERIENCED SYMPTOMS CONSISTENT WITH CHEMICAL BURNS OR A TOXIC/ALLERGIC REACTION. I'M REQUESTING THE FDA INVESTIGATE THIS PRODUCT'S SAFETY AND MANUFACTURING. RELINE UPPER DENTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1601739 DENTEMP SOFT-GRIP DENTURE RELINER RELINER, DENTURE, OVER THE COUNTER EBP DOC BRANDS, INC. 535-3637

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Female Other ROUX-EN-Y GASTRIC BYPASS 2007.| SMOKES (NOT DURING APPLICATION PROCESS), OCCASIONALLY DRINKS ALCOHOL.