BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LNCS INFANT SPO2 ADHESIVE SENSOR

    MDR report key: 1288688 · Received December 22, 2008

    Report

    Report Number
    1288688
    Event Type
    Injury
    Date Received
    December 22, 2008
    Date of Event
    December 8, 2008
    Report Date
    December 22, 2008
    Manufacturer
    MASIMO
    Product Code
    DQA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT HAD A MASIMO SET LNCS PROBE PLACED ON TOE. UPON ASSESSMENT, STAFF REPORTED SKIN BREAKDOWN. ABOUT NINE DAYS LATER, WOUND CARE NURSE REPORTED THAT ON THE UNDERSIDE OF THE LEFT BIG TOE, PATIENT HAD SKIN BREAKDOWN WITH BURN TYPE LESION MEASURING 1.5 X .5 CM. STAFF REPORT THAT THE WOUND WAS BLACKENED, NECROTIC AND UNSTAGEABLE. WOUND CARE NURSE REPORTS THAT SKIN IS HEELING AND ESCHAR IS DROPPING.====================== MANUFACTURER RESPONSE FOR SPO2 ADHESIVE SENSOR, LNCS INFANT SPO2 ADHESIVE SENSOR======================THEY HAVE BEEN ASSISTING WITH TROUBLESHOOTING, BUT HAVE NOT HAD ANY EXPERIENCE WITH THESE TYPES OF SKIN BREAKDOWNS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LNCS INFANT SPO2 ADHESIVE SENSOR SENSOR, OXIMETER DQA MASIMO LNCS INF *

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR Other| R CARDIAC DRUGS| CARDIAC DRUGS