BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COVIDIEN

    MDR report key: 2450213 · Received February 8, 2012

    Report

    Report Number
    MW5024209
    Event Type
    Injury
    Date Received
    February 8, 2012
    Date of Event
    February 7, 2012
    Report Date
    February 8, 2012
    Manufacturer
    COVIDIEN
    Product Code
    DQA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A (B)(6) MALE WITH COVIDIEN NELLCOR PULSE OXIMETER ON R INDEX FINGER DURING 2 DAY HOSPITALIZATION. UPON REMOVAL OF PULSE OXIMETER, WAS FOUND TO HAVE APPROXIMATELY 0.5CM BLISTER/BURN JUST DISTAL TO NAIL BED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COVIDIEN PULSE OXIMETER DQA COVIDIEN NELLCOR NEONATAL-ADULT UNKNOWN
    2 COVIDIEN NEONATAL-ADULT SPO2 SENSOR DQA COVIDIEN NELLCOR NEONATAL-ADULT UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR