BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REN - HARDWARE

    MDR report key: 1413446 · Received July 9, 2009

    Report

    Report Number
    1423500-2009-00315
    Event Type
    Injury
    Date Received
    July 9, 2009
    Date of Event
    June 1, 2009
    Report Date
    June 25, 2009
    Manufacturer
    UNKNOWN MFG FACILITY
    Product Code
    KDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE INVOLVED IN THIS EVENT IS UNKNOWN AND NO SERIAL NUMBER HAS BEEN PROVIDED. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF AN EVAL OR IF ANY ADDITIONAL INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    CENTER FOR ONE BAXTER CUSTOMER RESPONSE CONSULTANT (CFOB CRC) NOTIFIED CORPORATE PRODUCT SURVEILLANCE OF A REPORT FROM A FOREIGN PT IN 2009, REGARDING ANOTHER UNSPECIFIED PT WHO ALLEGEDLY CONTRACTED HEPATITIS C AND B FROM A DIALYSIS CLINIC. THE CALLER EXPRESSED CONCERN ABOUT CONTRACTING THE DISEASE HIMSELF. THE CALLER STATED THAT HE DOES NOT ALLEGE ANY PROBLEM WITH A BAXTER PRODUCT. THE CALLER INDICATED HE AND OTHER PTS FROM THE CLINIC ARE CONCERNED ABOUT THE CLINIC PROCEDURES. THE CALLER REQUESTED INFO FOR THEIR COUNTRY AND THE USA REGARDING THE AURORA HEMODIALYSIS MACHINE. NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REN - HARDWARE UNKNOWN KDI UNKNOWN MFG FACILITY

    Patients

    Seq Age Sex Outcome Treatment
    1 Other