BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOX RIP BELT

    MDR report key: 10275118 · Received July 15, 2020

    Report

    Report Number
    3007389703-2020-00003
    Event Type
    Injury
    Date Received
    July 15, 2020
    Date of Event
    June 9, 2020
    Report Date
    July 13, 2020
    Manufacturer
    NOX MEDICAL
    Product Code
    MNR
    UDI-DI
    15694311110187
    PMA / PMN Number
    K151361
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE USED FOR THE HOME SLEEP TEST WAS DISCARDED AFTER THE STUDY AND THEREFORE NOT AVAILABLE FOR ANALYSIS. THE DEVICE MANUFACTURING PRODUCTION DOCUMENTATION WAS REVIEWED AND SHOWED THAT THE PRODUCT LOTS PASSED ALL INCOMING, IN-PROCESS AND RELEASE TESTING WITH NO FAILURES OR NEED FOR RE-WORK. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    THE PATIENT DESCRIBED THAT THEY DEVELOPED CONTACT DERMATITIS ON THE ARMS AFTER UNDERGOING A HOME SLEEP STUDY WITH THE DEVICE WHICH REQUIRED ADMINISTRATION OF ORAL STEROIDS TO TREAT THE RASH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    739436 NOX RIP BELT RESPIRATORY EFFORT SENSOR MNR NOX MEDICAL NOX RIP BELT DISPOSABLE, LARGE 190304 15694311110187

    Patients

    Seq Age Sex Outcome Treatment
    1 Other