BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE-A-PORT

    MDR report key: 200815 · Received December 9, 1998

    Report

    Report Number
    1056436-1998-00116
    Event Type
    Injury
    Date Received
    December 9, 1998
    Date of Event
    September 7, 1994
    Report Date
    November 13, 1998
    Manufacturer
    HORIZON MEDICAL PRODUCTS, INC.
    Product Code
    LJT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ON 11/13/1998, THE NURSE FOR THE ATTORNEY CONTACTED THE MANUFACTURER'S CUSTOMER SERVICE DEPARTMENT AND REQUESTED TO SPEAK TO SOMEONE CONCERNING THIS EVENT. ON 11/16/1998, THE NURSE FOR THE ATTORNEY INFORMED THE MANUFACTURER'S REPRESENTATIVE OF THE FOLLOWING: THE DEVICE WAS IMPLANTED ON 12/07/1991. THE DEVICE WAS FOUND TO BE COILED AND WAS NO LONGER INFUSING. AS A RESULT, THE DEVICE WAS EXPLANTED ON 09/07/1994. THE CATALOG/LOT NUMBER AND LOCATION OF THE DEVICE IS UNKNOWN. THE NURSE FOR THE ATTORNEY WAS REQUESTING INFORMATION (CLINICIAN'S MANUAL, PATIENT'S MANUAL ETC.) REGARDING INFUSE-A-PORTS SO THEY COULD EVALUATE IF THIS PATIENT HAD A CASE OR NOT. THE MANUFACTURER'S REPRESENTATIVE INFORMED THE NURSE FOR THE ATTORNEY THAT THE MANUFACTURER WAS AQUIRED BY ANOTHER MANUFACTURER IN JULY 1997, AND THAT SHE WOULD HAVE TO CONTACT THE PREVIOUS/CURRENT OWNER'S LEGAL DEPARTMENTS REGARDING THIS INCIDENT. NO FURTHER DETAILS ARE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSE-A-PORT Implant VASCULAR ACCESS DEVICE LJT HORIZON MEDICAL PRODUCTS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention