BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GRANUFLO

    MDR report key: 2823060 · Received October 26, 2012

    Report

    Report Number
    MW5027492
    Event Type
    Injury
    Date Received
    October 26, 2012
    Date of Event
    October 25, 2012
    Report Date
    October 26, 2012
    Manufacturer
    FRESENIUS MEDICAL GROUP
    Product Code
    KPO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    I READ AN ARTICLE STATING THAT THE FDA HAS RECALLED GRANUFLO THAT IS MFG BY FRESENIUS MEDICAL GROUP, AND MY MOTHER HAS DIALYSIS 3 TIMES A WEEK, BY A (B)(6) CENTER, AND THEY ARE STILL USING THEIR GRANUFLO. SINCE MY MOM STARTED DIALYSIS 5 YRS AGO, SHE HAS SUFFERED A HEART ATTACK, AND HAS A LOT OF CARDIAC PROBLEMS, AND CHEST PAIN. HER (B)(6) CENTER ADMITTED YESTERDAY DURING HER TREATMENT THAT THEY ARE STILL USING THEIR GRANUFLO. ISN'T THAT ILLEGAL TO USE SOMETHING THAT HAS BEEN RECALLED? I ALSO SAW A COMMERCIAL ABOUT LAWSUITS FOR THIS VERY PROBLEM. I AM CONCERNED THAT THEY ARE STILL USING A PRODUCT THAT YOU HAVE RECALLED BECAUSE OF CARDIAC PROBLEMS, AND SUDDEN DEATH. PLEASE LET ME KNOW IF WHAT THEY ARE DOING IS OKAY AND SAFE. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GRANUFLO NONE KPO FRESENIUS MEDICAL GROUP

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other