BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYBENX GEL

    MDR report key: 18204869 · Received November 22, 2023

    Report

    Report Number
    MW5148452
    Event Type
    Injury
    Date Received
    November 22, 2023
    Date of Event
    November 13, 2023
    Report Date
    November 19, 2023
    Manufacturer
    EPIEN MEDICAL, INC.
    Product Code
    KJJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THIS IS FOR HYBENX GEL PRODUCT. AFTER APPLYING THE GEL, SEVERE IRRITATION OCCURRED ON BUCCAL MUCOSA AND GINGIVAL MARGIN WHERE PRODUCT WAS APPLIED. RINGING WITH WATER WERE PERFORMED PER INSTRUCTION BUT DID NOT HELP. THERE IS NO WARNING HOW SEVERELY THE PRODUCT CAN DAMAGE THE TISSUE IS STATED IN THE INSTRUCTION FOR USE, IFU (INSTRUCTION FOR USE). THIS LOT IS EITHER HAS A PRODUCTION ISSUE OR THERE IS NOT SUFFICIENT WARNING IN THE IFU FOR THE SEVERELY DAMAGING THE TISSUE. LOT NUMBER IS: P34SG, EXP: 2025/03/22.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1252013 HYBENX GEL CLEANSER, ROOT CANAL KJJ EPIEN MEDICAL, INC. P34SG

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Other| R