BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENA TECH

    MDR report key: 431971 · Received December 9, 2002

    Report

    Report Number
    2523676-2002-00067
    Event Type
    Injury
    Date Received
    December 9, 2002
    Report Date
    November 21, 2002
    Manufacturer
    B. BRAUN MEDICAL, INC.
    Product Code
    DTK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    USER FACILIY REPORTS THE FOLLOWING: PT MEDICAL HX AND AGE UNK WITH A NORMAL VENA CAVA DIAMETER. TWO WEEKS AFTER IMPLANTATION 2002, THE FILTER WAS FOUND DURING DIAGNOSITC CHEST FILM TO LOOK FOR PNEUMONIA, EVULSED AND LOCATED NEAR RIGHT ATRIUM. PT SUFFERED NO ADVERSE SEQUELAE TO THIS EVENT AND IS TO BE OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENA TECH VENA CAVA FILTER DTK B. BRAUN MEDICAL, INC. NA 0355730

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other