BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VORTEX PORT-AC WITH KIT

    MDR report key: 323241 · Received March 30, 2001

    Report

    Report Number
    1056436-2001-00037
    Event Type
    Injury
    Date Received
    March 30, 2001
    Date of Event
    March 2, 2001
    Report Date
    March 30, 2001
    Manufacturer
    HORIZON MEDICAL PRODUCTS, INC.
    Product Code
    LJT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IN 03/2001, THE USER FACILITY'S GENERAL SURGEON INFORMED THE MFR'S SENIOR ACCOUNT MANAGER OF THE FOLLOWING: "BOOT CRACKING".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14159 VORTEX PORT-AC WITH KIT VASCULAR ACCESS DEVICE LJT HORIZON MEDICAL PRODUCTS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention