BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BAD DRAGON CLEAR CUM LUBE WATER BASED LUBRICANT, BAD DRAGON CUM LUBE

    MDR report key: 22177853 · Received June 10, 2025

    Report

    Report Number
    MW5171223
    Event Type
    Malfunction
    Date Received
    June 10, 2025
    Date of Event
    June 4, 2025
    Report Date
    June 5, 2025
    Manufacturer
    UNK
    Product Code
    NUC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I HAVE BEEN USING BAD DRAGON CUM LUBE, WHICH CONTAINS POLYETHYLENE OXIDE (PEO) AS A THICKENING INGREDIENT. THE PRODUCT IS LABELED AS NON-TOXIC AND SAFE FOR USE WITH SILICONE TOYS BUT DOES NOT DISCLOSE THE GRADE OR PURITY OF THE PEO USED. COSMETICGRADE PEO CAN CONTAIN IMPURITIES SUCH AS ETHYLENE OXIDE AND 1,4-DIOXANE, WHICH ARE KNOWN OR POSSIBLE CARCINOGENS. SINCE THIS PRODUCT IS OFTEN USED INTERNALLY, THERE IS CONCERN ABOUT POTENTIAL EXPOSURE TO THESE IMPURITIES. I AM REPORTING THIS PRODUCT QUALITY CONCERN TO REQUEST FDA REVIEW OF THE PRODUCT'S SAFETY, LABELING, AND INGREDIENT PURITY. NO ADVERSE HEALTH EVENT HAS OCCURRED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2201012 BAD DRAGON CLEAR CUM LUBE WATER BASED LUBRICANT, BAD DRAGON CUM LUBE LUBRICANT, PERSONAL NUC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Male Other CRESTOR| INSULIN| PUMP THERAPY