BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUANCE PRO GEL PLW MASK

    MDR report key: 15282949 · Received August 24, 2022

    Report

    Report Number
    2518422-2022-75456
    Event Type
    Injury
    Date Received
    August 24, 2022
    Date of Event
    August 12, 2022
    Report Date
    August 24, 2022
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    UDI-DI
    00606959012936
    PMA / PMN Number
    K122847
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    THE MANUFACTURER BECAME AWARE OF AN ALLEGATION FROM A USER THAT HIS NUANCE NASAL PILLOWS WERE CAUSING IRRITATION AND A BURNING SENSATION. USER STATED HE DID NOT WASH THE MASK PRIOR TO USAGE. THE USER ALSO STATED HE USES A DISINFECTANT CPAP CLEANER SPRAY TO CLEAN HIS EQUIPMENT. THE USER VISITED HIS PRIMARY CARE DOCTOR AND WAS PRESCRIBED ANTIBIOTICS. THE USER NO LONGER HAS THIS MASK AND WILL NOT BE RETURNING IT FOR EVALUATION. THIS MASK IS INTENDED TO PROVIDE AN INTERFACE FOR APPLICATION OF CPAP OR BI-LEVEL THERAPY TO PATIENTS. THE MASK IS FOR SINGLE PATIENT USE IN THE HOME OR MULTI-PATIENT USE IN THE HOSPITAL/INSTITUTIONAL ENVIRONMENT. THE MASK IS TO BE USED ON PATIENTS (>66LBS/30KG) FOR WHOM CPAP OR BI-LEVEL THERAPY HAS BEEN PRESCRIBED. THE PRODUCT INSTRUCTIONS STATE: HAND WASH THE ENTIRE MASK BEFORE FIRST USE. THE NON-FABRIC PARTS SHOULD BE HAND WASHED DAILY. HAND WASH IN WARM WATER WITH A MILD LIQUID DISH WASHING DETERGENT. RINSE THOROUGHLY. AIR DRY COMPLETELY BEFORE USE. THE WARNINGS STATE: · DO NOT USE BLEACH, ALCOHOL, CLEANING SOLUTIONS CONTAINING BLEACH OR ALCOHOL, OR CLEANING SOLUTIONS CONTAINING CONDITIONERS OR MOISTURIZERS. ANY DEVIATION FROM THESE INSTRUCTIONS MAY IMPACT THE PERFORMANCE OF THE PRODUCT. THIS REPORT WILL BE FILED AS AN INITIAL-FINAL REPORT. THE MANUFACTURER CONCLUDES NO FURTHER ACTION IS NEEDED AT THIS TIME. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2324864 NUANCE PRO GEL PLW MASK VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. 1105167 00606959012936

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Other