BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 14443709 · Received May 19, 2022

    Report

    Report Number
    1820334-2022-00814
    Event Type
    Injury
    Date Received
    May 19, 2022
    Report Date
    May 18, 2022
    Manufacturer
    COOK INC
    Product Code
    DTK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER (PERSON) NOT PROVIDED, INFORMATION PROVIDED BY (B)(6) LLC OCCUPATION: NON-HEALTHCARE PROFESSIONAL. INVESTIGATION: UNKNOWN IF THE REPORTED DEATH IS DIRECTLY RELATED TO THE FILTER AND UNABLE TO IDENTIFY A CORRESPONDING FAILURE MODE AT THIS POINT IN TIME. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Description of Event or Problem · 0

    IT IS ALLEGED THAT "PATIENT RECEIVED A COOK TULIP FILTER. PATIENT IS ALLEGING DEATH. HOSPITAL AND MEDICAL RECORDS HAVE NOT BEEN PROVIDED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2230488 UNKNOWN DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK COOK INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Life Threatening