BEUDAMED
    FDA Adverse Event Other Summary report: N

    CHEMO-CATH

    MDR report key: 553468 · Received November 4, 2004

    Report

    Report Number
    2925153-2004-00021
    Event Type
    Other
    Date Received
    November 4, 2004
    Report Date
    October 29, 2004
    Manufacturer
    HDC CORP.
    Product Code
    DQO
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CATHETER WAS BROKEN DURING REMOVAL AND A BIG PORTION OF THE CATHETER REMAINED IN THE DEEP VEIN. THE PT HAD TO UNDERGO A HEART CATHETERIZATION WHICH WAS SUCCESSFUL AND THE REST OF THE CATHETER WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHEMO-CATH CHEMO-CATH 6.6 FR DQO HDC CORP. 330-06 0108

    Patients

    Seq Age Sex Outcome Treatment
    1 4.9 YR Other