BEUDAMED
    FDA Adverse Event Other Summary report: N

    PHOTOPHERESIS PROCEDURAL KIT

    MDR report key: 558056 · Received November 23, 2004

    Report

    Report Number
    558056
    Event Type
    Other
    Date Received
    November 23, 2004
    Date of Event
    October 4, 2004
    Report Date
    November 23, 2004
    Manufacturer
    THERAKOS, INC.
    Product Code
    LNR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A PATIENT WAS HERE FOR CHRONIC GRAFT VERSUS HOST DISEASE. PART OF THE STERILE KIT HAD A CRACKED EDGE CREATING AN "OPENING". A FAMILY MEMBER WAS CONCERNED ABOUT POSSIBLE UNTOWARD EFFECTS. AT TIME OF OBSERVATION OF "BROKEN INTEGRITY OF PLASTIC" THE BONE MARROW TRANSPLANT SERVICES WAS NOTIFIED AND THE PATIENT WAS IMMEDIATELY DISCONNECTED. BLOOD CULTURES FROM BOTH VAXCEL LUMENS EMPIRIC ANTIBIOTICS, LEVAQUIN STARTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHOTOPHERESIS PROCEDURAL KIT PHOTOPHERSIS KIT LNR THERAKOS, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR IMMUNOTHERAPY