BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD

    MDR report key: 3020735 · Received March 7, 2013

    Report

    Report Number
    MW5029448
    Event Type
    Injury
    Date Received
    March 7, 2013
    Report Date
    March 7, 2013
    Manufacturer
    C.R. BARD, INC. (GFO)
    Product Code
    DTK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    DC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2012, 'PT (B)(6)' HAD AN IVC FILTER PLACED IN PREPARATION FOR UNDERGOING GASTRIC BYPASS SURGERY. GASTRIC BYPASS SURGERY WAS COMPLETED ON (B)(6) 2012. PT (B)(6) WAS DISCHARGED TO HOME ON (B)(6) 2012 W/O ANY COMPLICATIONS. ON (B)(6) 2012, PT (B)(6) UNDERWENT A PROCEDURE TO REMOVE THE IVC FILTER. WHEN THE IVC FILTER WAS REMOVED, IT WAS EXAMINED. THE FILTER HAD 6 "LEGS" BUT ONLY 5 "SHOULDERS". AT THIS POINT, IT WAS DISCOVERED THAT THE FILTER SHOULDER HAD BECOME UNATTACHED FROM THE DEVICE AND WAS NOW LOCATED IN THE LEFT CHEST AREA (INSIDE THE PT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98630 BARD BARD MERIDIAN IVC FILTER DTK C.R. BARD, INC. (GFO) GFWA0433

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| R