BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRAINAGE SET

    MDR report key: 235255 · Received August 13, 1999

    Report

    Report Number
    1820334-1999-00072
    Event Type
    Injury
    Date Received
    August 13, 1999
    Date of Event
    June 25, 1999
    Report Date
    July 16, 1999
    Manufacturer
    COOK, INC.
    Product Code
    FGE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE CATHETER WAS INSERTED BY USUAL SELDINGER TECHNIQUE INTO THE PT FOR "PTCD" DRAINAGE ON JUNE 25, 1999. ABOUT TWO OR THREE DAYS AFTER PLACEMENT, THE DR EXPERIENCED THAT THE CATHETER WOULD NOT DRAIN. UPON IMAGING, THE DR FOUND THE CATHETER WAS SEPARATED. THE SEPARATED SEGMENT WAS RETRIEVED BY ABDOMINAL OPERATION USING A THREAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRAINAGE SET Implant DRAINAGE SET FGE COOK, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention