BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATO MEDICAL

    MDR report key: 83878 · Received February 9, 1995

    Report

    Report Number
    83878
    Event Type
    Injury
    Date Received
    February 9, 1995
    Date of Event
    December 1, 1994
    Report Date
    December 15, 1994
    Manufacturer
    STRATO MEDICAL CORP
    Product Code
    LJT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    11/30/94 PORT PLACEMENT. 12/1/94 PORT LEAKING; LEAKING FROM NEEDLE INSERTION SITE. 12/2/94 PORT REMOVED; LONGITUDINAL TEAR. MD QUESTIONED OUTFLOW OBSTRUCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRATO MEDICAL Implant INFUSAPORT/LIFEPORT LJT STRATO MEDICAL CORP LPS 5513 *

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention