BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NONIN WRISTOX2 PULSE OXIMETER

    MDR report key: 9680513 · Received February 7, 2020

    Report

    Report Number
    3007389703-2020-00002
    Event Type
    Injury
    Date Received
    February 7, 2020
    Date of Event
    January 30, 2020
    Report Date
    February 5, 2020
    Manufacturer
    NONIN MEDICAL INC.
    Product Code
    DQA
    PMA / PMN Number
    K102350
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NOX MEDICAL IS A REPACKAGER OF THE NONIN 3150 PULSE OXIMETER, THAT IS INCLUDED IN THE NOX T3 SYSTEM. THE LEGAL MANUFACTURER OF THE FINISHED DEVICE IS NONIN MEDICAL INC. THAT HAS BEEN NOTIFIED OF THE REPORTED EVENT. THE SUSPECTED DEVICE WILL BE SENT DIRECTLY FROM NOX MEDICAL LLC (THE IMPORTER AND DISTRIBUTOR) TO NONIN MEDICAL (THE FINISHED DEVICE LEGAL MANUFACTURER) FOR FURTHER EVALUATION. NOX MEDICAL HAS EVALUATED THE INFORMATION RELATED TO THIS REPORTED EVENT AND CAME TO THE CONCLUSION THAT THE INCIDENT IS NOT RELATED TO THE REPACKAGING OF THE NONIN 3150 PULSE OXIMETER PERFORMED BY NOX MEDICAL. ANY FURTHER REPORTS WILL COME FROM NONIN MEDICAL INC. THE FINISHED DEVICE LEGAL MANUFACTURER.

    Description of Event or Problem · 1

    MR. (B)(6) CALLED AND DESCRIBED GOING TO BED 10-11 PM, HE WAS AWAKENED BY STINGING SENSATION AROUND 3-4 AM. HE THEN TOOK THE DEVICE OFF AND PLACED ICE CUBES ON HIS BURN SITE (RIGHT HAND/WRIST AREA). BURN INJURY ON WRIST AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145121 NONIN WRISTOX2 PULSE OXIMETER WRIST-WORN PULSE OXIMETER DQA NONIN MEDICAL INC. MODEL 3150

    Patients

    Seq Age Sex Outcome Treatment
    1 Other