BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIOPTIX

    MDR report key: 6590261 · Received May 23, 2017

    Report

    Report Number
    MW5070014
    Event Type
    Injury
    Date Received
    May 23, 2017
    Date of Event
    April 17, 2017
    Report Date
    May 23, 2017
    Manufacturer
    VIOPTIX, INC.
    Product Code
    MUD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE VIOPTIX DEVICE SUPPLIED TISSUE OXYGENATION READINGS OF A PATIENT'S POST-MASTECTOMY BILATERAL BREAST FLAPS THAT WERE WITHIN NORMAL RANGE. HOWEVER, THE PATIENT'S CLINICAL PRESENTATION WAS INCONSISTENT WITH THE NORMAL OXYGENATION READINGS. DESPITE THE NORMAL READINGS PROVIDED BY DEVICE, THE PATIENT'S BREAST TISSUE WAS NOT WELL PERFUSED AND THE FLAP DECOMPENSATED. THE PATIENT HAD AN UNSCHEDULED RETURN TO SURGERY FOR DEBRIDEMENT AND REVISION OF THE FLAPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    365104 VIOPTIX TISSUE OXIMETER MUD VIOPTIX, INC. OXY-2

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Hospitalization