BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOX T3, NOXTURNAL

    MDR report key: 5696161 · Received June 2, 2016

    Report

    Report Number
    2021710-2016-03823
    Event Type
    Injury
    Date Received
    June 2, 2016
    Date of Event
    May 11, 2016
    Report Date
    May 11, 2016
    Manufacturer
    NOX MEDICAL
    Product Code
    MNR
    PMA / PMN Number
    K082113
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IMPORTER REPORT NUMBER: (B)(4). (B)(4). (B)(4) IS THE IMPORTER OF RECORD FOR THIS DEVICE. THE LEGAL MANUFACTURER (NOX MEDICAL) HAS BEEN NOTIFIED OF THE REPORTED EVENT. ANY FURTHER REPORTS WILL COME FROM THE LEGAL MANUFACTURER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ONE OF THEIR PATIENTS COMPLAINED THAT THE DEVICE ON THE WRIST BECAME HOT AROUND 2AM AND THE PATIENT AWOKE TO A BURNING SENSATION AND NOTICED REDNESS ON HIS ARM WITH A SMALL AREA OF WETNESS. HE IMMEDIATELY TOOK OFF THE DEVICE AND NOTED FLUID RESIDUE ON HIS ARM. HE WASHED HIS ARM FOR THREE TO FIVE MINUTES AND THEN APPLIED NEOSPORIN AND A DRESSING TO THE AREA. THE PATIENT THEN WENT BACK TO SLEEP AND WAS AWAKENED TO SLIGHT DISCOMFORT IN THE AREA HE HAD WASHED. THE PATIENT THEN WASHED THE AREA AGAIN AND NOTED A SCAB FORMING. WHEN THE PATIENT WOKE UP LATER THAT DAY HE WENT TO A CLINIC AND WAS TREATED BY A NURSE PRACTITIONER WHO STATED THAT THE PATIENT HAD A SECOND DEGREE BURN FROM THE HEAT OF THE DEVICE. THE BURN WAS IN A RECTANGULAR SHAPE WITH A BLACKISH STAIN, IT WAS APPROXIMATELY 2.5 INCHES BY 0.5 INCHES ON THE ANTERIOR OF THE ARM, APPROXIMATELY 3 INCHES FROM THE WRIST. THE PATIENT'S ARM WAS CLEANED BY THE NURSE PRACTITIONER AND NEOSPORIN AND A COUPLE OF 2X2 DRESSINGS WERE APPLIED TO THE SITE ALONG WITH COBAN TO SECURE THE DRESSING. THE PATIENT WAS THEN SENT HOME AND INSTRUCTED TO GO TO THE EMERGENCY ROOM IF THEY NOTICED ANY SIGNS OF INFECTION. THE PATIENT HAS SINCE REPORTED THAT THEY ARE HEALING JUST FINE. THE DEVICE WAS RETURNED TO THE CUSTOMER BY THE PATIENT AND THE PATIENT WAS SENT TO A CLINIC FOR THE COMPLETION OF THE SLEEP STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348317 NOX T3, NOXTURNAL VENTILATORY EFFORT RECORDER MNR NOX MEDICAL T3 SLEEP MONITOR

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other