BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYO-CELL INTERNATIONAL, INC.

    MDR report key: 564855 · Received November 30, 2004

    Report

    Report Number
    MW1034156
    Event Type
    Injury
    Date Received
    November 30, 2004
    Date of Event
    January 1, 2004
    Report Date
    November 12, 2004
    Manufacturer
    *
    Product Code
    KSE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    RPTR USED CRYO-CELL TO STORE CORD BLOOD. SINCE 7/2004, RPTR ASKED CYRO-CELL ABOUT THE NEW STATEMENT IN ORDER TO PAY FOR STORAGE FEE WITHOUT ANY RESPONSE. RPTR STARTED TO SUSPECT IF THE CORD BLOOD IS IN GOOD SHAPE AND SECURE. CONTACTED THE CO SEVERAL TIMES WITHOUT SUCCESS. CONTACTED THEM BY PHONE, MAIL, E-MAIL FOR 3 MONTHS. FINALLY, THEY RESPONDED TO PHONE CALLS & E-MAIL IN OCT., SAYING THAT THEY WOULD INVESTIGATE. RPTR WROTE AN E-MAIL & CALLED THEM ONE MONTH LATER (NOV.). THEY STILL COULD NOT TELL RPTR THE SECURITY OF THE HUMAN CELLULAR/TISSUE PRODUCT. RPTR ONLY RECEIVED A LETTER TELLING THEM THAT ALL THE PRODUCTS WILL BE MOVED TO A NEW FACILITY. RPTR IS VERY CONCERNED ABOUT THE SAFETY AND SECURITY. BECAUSE OF THEIR DELAY OF RESPONSE & THEY CAN'T TELL RPTR THE SECURITY OF THE CORD BLOOD, CUSTOMERS' WELFARE IS COMPROMISED AND RPTR FEELS THAT THE CO MIGHT DISCARD THE SPECIMENS WHILE CHARGING RPTR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYO-CELL INTERNATIONAL, INC. BLOOD CELL STORAGE KSE * * *

    Patients

    Seq Age Sex Outcome Treatment
    1 27 MO Required Intervention