BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BCI INTERNATIONAL

    MDR report key: 226199 · Received June 3, 1999

    Report

    Report Number
    MW1016455
    Event Type
    Injury
    Date Received
    June 3, 1999
    Date of Event
    April 15, 1999
    Report Date
    May 21, 1999
    Manufacturer
    BCI INTERNATIONAL, INC.
    Product Code
    DQA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER ON 7/19/1999: BCI IS CURRENTLY WAITING FOR THE RESULTS OF THIRD PARTY EVALUATIONS OF THE DEVICES. A COMPLETE REPORT WILL BE SENT AFTER THE RESULTS ARE IN. THIS SHOULD OCCUR WITHIN THE NEXT WEEK OR SO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BCI INTERNATIONAL PULSE OXIMETER DQA BCI INTERNATIONAL, INC. 3303 *

    Patients

    Seq Age Sex Outcome Treatment
    1 6 MO Required Intervention