BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CPAP MASK (GENERAL REFERENCE)

    MDR report key: 22938483 · Received September 2, 2025

    Report

    Report Number
    MW5175464
    Event Type
    Injury
    Date Received
    September 2, 2025
    Date of Event
    July 14, 2025
    Report Date
    August 26, 2025
    Manufacturer
    RESPLABS MEDICAL USA INC.
    Product Code
    LRJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA
    Reporter Occupation
    003
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    UNOPENED "RESPLABS CPAP (CONTINUOUS POSITIVE AIRWAY PRESSURE) MASK CLEANING WIPES" (LOT R-10199) PURCHASED DIRECTLY FROM AMAZON FBA WERE TESTED BY AN INDEPENDENT ISO-CERTIFIED LAB (MATEXCEL). RESULTS: TOTAL AEROBIC COUNT 1.5 × 10? CFU/G AND YEAST & MOLD 7.7 × 10? CFU/G. BOTH VALUES EXCEED USP/ISO MICROBIAL SAFETY THRESHOLDS BY MORE THAN 100-FOLD. COMPOSITION ANALYSIS FOUND BENZALKONIUM CHLORIDE ONLY 0.04¿0.06%, FAR BELOW RECOGNIZED ANTIMICROBIAL LEVELS. HUNDREDS OF CONSUMER REVIEWS SINCE 2021 REPORT MOLD, FOUL ODOR, AND ADVERSE REACTIONS. THESE WIPES ARE MARKETED FOR CPAP MASK CLEANING (RESPIRATORY EXPOSURE PATHWAY IN ELDERLY/IMMUNOCOMPROMISED USERS). THIS CONSTITUTES A SIGNIFICANT CONTAMINATION HAZARD. RESULT IS EXPRESSED IN CFU/G (COLONY-FORMING UNITS PER GRAM). EXCEEDS USP/ISO MICROBIAL LIMIT (~150× HIGHER FOR BACTERIA, ~770X HIGHER FOR MOLD).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2332334 CPAP MASK (GENERAL REFERENCE) DISINFECTANT, MEDICAL DEVICES LRJ RESPLABS MEDICAL USA INC. R-10199

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention