BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN

    MDR report key: 6372331 · Received March 2, 2017

    Report

    Report Number
    1820334-2017-00473
    Event Type
    Malfunction
    Date Received
    March 2, 2017
    Report Date
    May 3, 2017
    Manufacturer
    COOK INC
    Product Code
    DTK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE 510(K): K032426. (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE PROVIDED UPON CONCLUSION.

    Additional Manufacturer Narrative · 1

    CORRECTION: DEVICE HAS NOT BEEN IDENTIFIED. LOT NUMBER OR OTHER PRODUCT IDENTIFICATIONS WERE NOT PROVIDED. THE EVENT IS CURRENTLY UNDER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE PROVIDED UPON CONCLUSION.

    Additional Manufacturer Narrative · 1

    THE EVENT IS CURRENTLY UNDER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED 3/8/2017 - PATIENT ALLEGES THAT AN IVC FILTER WAS IMPLANTED ON (B)(6) 2006. THE FILTER WAS PLACED TO PREVENT PE AFTER AN EMERGENCY PULMONARY EMBOLECTOMY ON CARDIOPULMONARY BYPASS. NO ATTEMPT TO REMOVE FILTER. ON (B)(6) 2015 SCAN OF IVC FILTER DID NOT INDICATE ANY ISSUES WITH FILTER. PATIENT ALLEGES DVT AND WORRY/CONCERN ABOUT FUTURE POSSIBLE EVENTS RELATED TO THE FILTER.

    Description of Event or Problem · 1

    IT IS ALLEGED THAT "[PT] RECEIVED A COOK GUNTHER TULIP ON (B)(6) 2006.¿ IT IS ALLEGED THAT THE PATIENT WAS INJURED WITHOUT FURTHER EXPLANATION. HOSPITAL AND MEDICAL RECORDS HAVE BEEN REQUESTED BUT NOT YET PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156888 UNKNOWN DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK COOK INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other