BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE OXIMETER

    MDR report key: 17885 · Received November 21, 1994

    Report

    Report Number
    MW1004093
    Event Type
    Injury
    Date Received
    November 21, 1994
    Date of Event
    September 28, 1994
    Report Date
    November 4, 1994
    Manufacturer
    NONIN MEDICAL, INC.
    Product Code
    DQA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT INCURRED BURN ON FINGER TO WHICH PULSE OXIMETER WAS ATTACHED. THIS RESULTED IN A 2ND DEGREE BURN WITH BLISTER FORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE OXIMETER PULSE OXIMETER DQA NONIN MEDICAL, INC. 8604

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention