BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITAL PORT VASCULAR ACCESS SYSTEM

    MDR report key: 29148 · Received December 28, 1995

    Report

    Report Number
    MW1008014
    Event Type
    Injury
    Date Received
    December 28, 1995
    Date of Event
    December 19, 1995
    Report Date
    December 19, 1995
    Manufacturer
    HORIZON MEDICAL PRODUCTS, INC.
    Product Code
    LJT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    HMP/NEOSTAR MED TECHNOLOGIES. THE ENCLOSED REPORT (#1008014) INDICATES A DEVICE WHICH WAS DISTRIBUTED BY HORIZON MED PRODUCTS, INC. BUT WAS NOT MFG BY HORIZON MED PRODUCTS, INC. THE DEVICE IS A COOK PACEMAKER CORP. CAT NUMBER IPS-9010, SN 011125. HORZON MED PRODUCTS, INC. HAS NO RECORD OF RECEIVING THIS COMPLAINT OR THE DEVICE IN QUESTION FROM TWIN LAKES REG MED CTR. HOWEVER, A REVIEW OF OUR RECORDS DOES INDICATE THAT THE DEVICE WAS DISTRIBUTED BY HMP. PER THE REQUIREMENTS OF 21 CFR SECTION 803, WE ARE FILING THIS DISTRIBUTOR MDR REPORT AND HAVE CONTACTED THE MFR. OUR INTERNAL COMPLAINT REF IS H0139. IF YOU HAVE ANY QUESTIONS OR DESIRE ADD'L INFO, PLEASE DO NOT HESITATE TO CONTACT ME DIRECTLY AT 610-337-1277.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITAL PORT VASCULAR ACCESS SYSTEM Implant PORT LJT HORIZON MEDICAL PRODUCTS, INC. 9010

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention