BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 212330 · Received March 3, 1999

    Report

    Report Number
    MW1015816
    Event Type
    Injury
    Date Received
    March 3, 1999
    Date of Event
    December 25, 1998
    Report Date
    March 3, 1999
    Manufacturer
    ALLEGIANCE HEALTHCARE CORP.
    Product Code
    KOD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ADDITIONAL INFO RECEIEVED FROM THE MFR ON 04/01/1999: THE CO HAS BEEN NOTIFIED OF THE REPORT. AS PER DISTRIBUTER'S REQUIREMENTS, THE CO HAS NOTIFIED AND PROVIDED THE SUPPLIER WITH A COPY OF THIS REPORT. BASED UPON THE INFORMATION CONTAINED IN THIS REPORT, THE CO HAS DETERMINED THAT THE CRITERIA FOR REPORT FILING HAS NOT BEEN MET. THE CO IS NOT THE MFR OF THIS PRODUCT, THEREFORE, THE CO IS NOT SUBMITTING A REPORT. THE CO HAS, HOWEVER, NOTIFIED THE SUPPLIER OF THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK STRAIGHT CATH KIT KOD ALLEGIANCE HEALTHCARE CORP. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR