BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BCI REUSABLE OXIMETRY FINGER SENSOR

    MDR report key: 1910197 · Received November 22, 2010

    Report

    Report Number
    2183502-2010-00543
    Event Type
    Injury
    Date Received
    November 22, 2010
    Date of Event
    October 20, 2010
    Report Date
    November 18, 2010
    Manufacturer
    SMITHS MEDICAL MD
    Product Code
    DQA
    PMA / PMN Number
    K974697
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MFR FOR DEVICE EVAL. WHEN AND IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED THE MFR WILL FILE A F/U REPORT DETAILING THE RESULTS OF THE EVAL.

    Description of Event or Problem · 1

    A REPORT WAS REC'D THAT STATED THE END USER REPORTED THAT THE FINGER PROBE CAUSED BLISTERING OF THE FINGERTIP. NO LASTING MEDICAL SEQUELA REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BCI REUSABLE OXIMETRY FINGER SENSOR DQA - PULSE OXIMETER (ACCESSORY) DQA SMITHS MEDICAL MD 3444 4003884

    Patients

    Seq Age Sex Outcome Treatment
    1 NONE Other