BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD 15 FRENCH J-VAC DRAIN

    MDR report key: 1386567 · Received May 14, 2009

    Report

    Report Number
    MW5011116
    Event Type
    Injury
    Date Received
    May 14, 2009
    Date of Event
    May 7, 2009
    Report Date
    May 14, 2009
    Manufacturer
    BARD MEDICAL DIVISION
    Product Code
    GCY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    POST-OP TOTAL KNEE REPLACEMENT PATIENT FROM 2009. PHYSICIAN ATTEMPTED TO REMOVE THE BARD DRAIN TWO DAYS LATER, THE DRAIN REMOVED WITH A SNAP. X-RAY WAS OBTAINED, IT REVEALED A PIECE OF THE DRAIN TO STILL BE PRESENT IN THE SUPRAPATELLAR POUCH. THERE WAS NOT DRAIN OUTSIDE THE SKIN. SHE WAS RETURNED TO THE OPERATING ROOM FOR EXTRACTION OF THE DRAIN FRAGMENT. THE PIECE WAS PULLED OUT OF THE JOINT AND SENT TO PATHOLOGY FOR IDENTIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD 15 FRENCH J-VAC DRAIN WOUND DRAIN GCY BARD MEDICAL DIVISION

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| S