BEUDAMED
    FDA Adverse Event Summary report: N

    PULSE OXIMETRY PROBE

    MDR report key: 3687325 · Received March 12, 2014

    Report

    Report Number
    3687325
    Date Received
    March 12, 2014
    Date of Event
    March 1, 2014
    Report Date
    March 12, 2014
    Manufacturer
    NIHON KOHDEN AMERICA, INC.
    Product Code
    DQA
    Report Source
    User Facility report
    Reporter Location
    NC, US

    Narratives

    Description of Event or Problem · 1

    PATIENT COMPLAINED THE CONTINUOUS PULSE OXIMETRY PROBE ON HIS RIGHT INDEX FINGER KEPT COMING OFF. WHEN TRYING TO REINFORCE IT BACK ON FINGER, PATIENT COMPLAINED OF IT HURTING. WHEN THE PULSE OXIMETRY PROBE REMOVED, PATIENT WAS NOTED TO HAVE A POSSIBLE ABSCESS/PRESSURE ULCER ON HIS RIGHT INDEX FINGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148530 PULSE OXIMETRY PROBE OXIMETER DQA NIHON KOHDEN AMERICA, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other NOT APPLICABLE.