BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESCOMF

    MDR report key: 22460496 · Received July 9, 2025

    Report

    Report Number
    MW5172462
    Event Type
    Injury
    Date Received
    July 9, 2025
    Date of Event
    June 1, 2025
    Report Date
    July 4, 2025
    Manufacturer
    GUANG DONG EDA TECHNOLOGY CO., LTD.
    Product Code
    LRJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    AFTER USING THE RESCOMF CPAP MACHINE CLEANER, I BEGAN HAVING DIFFICULTY SPEAKING AND HAD TO SEE AN ENT SPECIALIST. I HAVE BEEN PRESCRIBED ADDITIONAL MEDICATIONS TO CORRECT THE ISSUES CAUSED BY THE RESCOMF. THE CHEMICALS LEAVE A STINGING IN MY THROAT AFTER I HAVE CLEANED MY MACHINE IN THE MORNING. THE STINGING LASTS FOR HOURS. THE DIFFICULTY IN SPEAKING HAS LASTED FOR OVER A MONTH. SOLD BY (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1279245 RESCOMF DISINFECTANT, MEDICAL DEVICES LRJ GUANG DONG EDA TECHNOLOGY CO., LTD. XD10025002904

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Disability