BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOK GUNTHER TULIP IVC FILTER

    MDR report key: 11684915 · Received April 16, 2021

    Report

    Report Number
    MW5100828
    Event Type
    Injury
    Date Received
    April 16, 2021
    Date of Event
    July 24, 2014
    Report Date
    April 14, 2021
    Manufacturer
    COOK MEDICAL LLC
    Product Code
    DTK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2010, I HAD A COOK GUNTHER TULIP IVC FILTER PLACED AT (B)(6). FROM 2011 TO 2013 I HAD SEVERAL PULMONARY EMBOLISMS SOME WHICH CAUSED A SMALL STROKE, LOSS OF HEARING IN MY RIGHT EAR. I ALSO HAD SEIZURES, AND TEMPORARILY I HAD PARALYSIS ON MY LEFT SIDE. ON (B)(6) 2013, I HAD A SURGERY BECAUSE CLOTS WERE TRAVELING IN MY BODY. I ASKED WHY THIS HAPPENED WHEN I HAVE A FILTER TO PREVENT THIS FROM HAPPENING. IN 2014 WHEN I ASKED FOR THE MANUFACTURER AND FOR MEDICAL DEVICE INFO, I WAS TOLD THERE WASN'T ANY DOCUMENTATION OR LABELING PRODUCT ID OR THE COMPANY AND TYPE OF FILTER. ON (B)(6) 2021 I RECEIVED A VOICEMAIL FROM MY PRIMARY DOCTOR (B)(6) THAT THE FILTER I HAD WAS A COOK GUNTHER TULIP FILTER, BUT THAT THERE ARE NO OTHER RECORDS JUST THE VERBAL ONE WHICH I ASKED FOR IT IN WRITING AND THAT WAS DENIED. ACCORDING TO THE (B)(6) ASSURED ME THAT THERE AREN'T ANY RECALLS OR DOCUMENTED WITH THIS TYPE OF IVC FILTER. I DON'T WANT ANYONE ELSE SUFFERING LIKE I HAVE, SO I WANTED TO NOTIFY WHOEVER ABOUT MY COMPLICATIONS AND ADVERSE SIDE EFFECTS FROM THE COOK GUNTHER TULIP IVC FILTER. FDA SAFETY REPORT ID#: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580049 COOK GUNTHER TULIP IVC FILTER FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK COOK MEDICAL LLC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Hospitalization| L| R| S