BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTY CYCLER

    MDR report key: 3821291 · Received May 9, 2014

    Report

    Report Number
    2937457-2014-00795
    Event Type
    Injury
    Date Received
    May 9, 2014
    Date of Event
    March 8, 2014
    Report Date
    March 28, 2014
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DUE TO LACK OF INFO A MDR'S WILL BE FILED AGAINST THE CYCLER WHILE UNDERGOING REVIEW BY POST MARKET CLINICAL DEPARTMENT AND MANUFACTURING PLANT. CURRENTLY, THE POST MARKET CLINICAL STAFF IS REQUESTING MEDICAL RECORDS. THIS REPORT WAS MANUALLY SUBMITTED ON (B)(6), 2014 WITHOUT THE MFG (MFR) NUMBER. THIS REPORT IS BEING RESUBMITTED TODAY WITH A NEWLY GENERATED MFR NUMBER.

    Description of Event or Problem · 1

    DURING A TELEPHONE CONVERSATION ON (B)(6) 2014 THE PT'S HUSBAND STATED THAT THE PT WENT INTO HOSP ON (B)(6) 2014 AND HAD A STROKE AND HER LEFT SIDE IS PARALYZED. ALSO, THE NEW CYCLER HAS ARRIVED AS OF THIS MORNING. THE PTS PD-NURSE WAS CONTACTED ON (B)(6) 2014. SHE STATED THAT THE PT WAS NOT ON THE CYCLER WHEN THE STROKE OCCURRED. CONFIRMED THAT THE PT IS IN THE HOSP. ADDITIONAL INFO WAS REQUESTED BUT IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282119 LIBERTY CYCLER FKX FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization