BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSAID

    MDR report key: 85154 · Received February 9, 1995

    Report

    Report Number
    85154
    Event Type
    Injury
    Date Received
    February 9, 1995
    Date of Event
    June 25, 1994
    Report Date
    September 6, 1994
    Manufacturer
    STRATO MEDICAL CORP.
    Product Code
    LJT
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT HAD A CATHETER INSERTED ON 2/25/94. PT WAS HOSPITALIZED ON 6/26/94 WITH A TEMPERATURE OF 103.1, SWELLING AND REDNESS, WARMTH, AND TENDERNESS AT THE CATHETER SITE. THE CATHETER WAS REMOVED ON 6/2694. THE PT RESPONDED TO TREATMENT WITH IV ANTIBIOTICS (CIPRO).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSAID Implant INFUS-A-PORT LJT STRATO MEDICAL CORP. NA 313305

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Life Threatening 6/17/94 TO 6/25/94.| PT WAS ON A CONTINUOUS DILAUDID DRIP FOR NINE DAYS