BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPLABS CPAP MASK WIPES 110 WIPES

    MDR report key: 23478654 · Received November 5, 2025

    Report

    Report Number
    MW5178534
    Event Type
    Malfunction
    Date Received
    November 5, 2025
    Date of Event
    November 1, 2025
    Report Date
    November 1, 2025
    Manufacturer
    RESPLABS MEDICAL USA INC.
    Product Code
    LRJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    DISCOVERED MOLD OR MILDEW, DARK SPOTS, ON MULTIPLE RESPLABS CPAP MASK WIPES. PRODUCTION DATE: 01/20/2025, LOT NUMBER R-09572. PURCHASED FROM AMAZON. I NOTICED QUITE A FEW AMAZON REVIEWS FROM OTHER CUSTOMERS WHO ALSO NOTED FINDING BLACK MOLD OR MILDEW ON THE WIPES. EMAILED THE COMPANY AND INCLUDED PICTURES OF THE MOLD AND LOT NUMBER. IT CANNOT BE SAFE TO INTRODUCE MOLDY WIPES TO A CPAP MASK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2279880 RESPLABS CPAP MASK WIPES 110 WIPES DISINFECTANT, MEDICAL DEVICES LRJ RESPLABS MEDICAL USA INC. R-09572

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown