BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NONE

    MDR report key: 1884073 · Received October 20, 2010

    Report

    Report Number
    1713747-2010-00041
    Event Type
    Injury
    Date Received
    October 20, 2010
    Report Date
    October 20, 2010
    Manufacturer
    OGDEN MANUFACTURING
    Product Code
    KDI
    PMA / PMN Number
    K002761
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE FACILITY HAS BEEN CONTACTED FOR ADDITIONAL INFORMATION ON THE EVENT. IT WAS LEARNED IN SPEAKING WITH THE INITIAL REPORTER THAT THE PATIENT HAD BEEN RECEIVING DIALYSIS WITH USE OF THIS PRODUCT FOR SOME TIME AND THAT THERE WERE NO RECENT CHANGES GOING ON WITH THE PATIENT. THIS EVENT OCCURRED EARLY IN THE AM AT 10 MINUTES INTO THE TREATMENT. ONCE TRANSPORTED TO THE ER, THE PATIENT UNDERWENT MEDICAL EVALUATION BY BOTH AN INTERNIST AND A NEPHROLOGIST. ACCORDING TO THE VERBAL REPORT BY THIS NURSE, THE MDS HAD FOUND NOTHING WRONG. IT WAS DECIDED TO DIALYZE THE PATIENT IN THE HOSPITAL UNIT. THERE IS NO SAMPLE. IT WAS ALSO REPORTED THAT THE PATIENT'S BLOOD WAS RETURNED AT THE TIME OF THE INCIDENT. NOTE: A REQUEST HAS BEEN MADE FOR THE TREATMENT SHEETS, HOWEVER, NO FURTHER INFORMATION HAS BEEN RECEIVED OTHER THAN THE VERBAL REPORT OF THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NONE KDI OGDEN MANUFACTURING NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other