BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENA TECH

    MDR report key: 15583866 · Received October 11, 2022

    Report

    Report Number
    3006332832-2022-00004
    Event Type
    Injury
    Date Received
    October 11, 2022
    Date of Event
    January 18, 2022
    Report Date
    October 11, 2022
    Manufacturer
    B. BRAUN MEDICAL
    Product Code
    DTK
    UDI-DI
    04038653918164
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). AS REPORTED BY THE USER FACILITY: VENATECH LP FILTER IMPLANTED INTO PATIENT ON OR ABOUT (B)(6), 2011 AFTER BEING DIAGNOSED WITH DEEP VEIN THROMBOSIS ('DVT) AND PULMONARY EMBOLUI ('PE'). ON OR ABOUT (B)(6), 2022 PATIENT UNDERWENT DIAGNOSTIC IMAGING. EXAMINATION OF THE IMAGING BY A QUALIFIED EXPERT RADIOLOGIST SHOWED MULTIPLE STRUTS FRACTURED IN THE VICINITY OF THE LOWER THORACIC SPINE. PATIENT IS AT RISK FOR FUTURE MIGRATIONS, FRACTURES AND PERFORATIONS FROM THE RETAINED VENATECH LP FILTER, AND FACES NUMEROUS HEALTH RISKS, INCLUDING THE RISK OF DEATH. PATIENT WILL REQUIRE ONGOING MEDICAL CARE AND MONITORING FOR THE REST OF HIS LIFE. IT SHOULD BE NOTED THE ACTUAL PRODUCT CODE WAS NOT LISTED IN THE DOCUMENT AND A BATCH NUMBER WAS NOT PROVIDED TO ASSIST IN VERIFY THE ACTUAL PRODUCT CODE. THE PRODUCT CODE USED IS THE CODE FOR THE VENA TECH LP FILTER AS LISTED IN THE DOCUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2350983 VENA TECH FILTER, INTRAVASCULAR, CAR DTK B. BRAUN MEDICAL 5010024 04038653918164

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other