BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPORT

    MDR report key: 20591 · Received March 1, 1995

    Report

    Report Number
    20591
    Event Type
    Malfunction
    Date Received
    March 1, 1995
    Date of Event
    September 1, 1994
    Report Date
    September 13, 1994
    Manufacturer
    STRATO MEDICAL CORP.
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PROCEDURE: INSERTION OF LIFEPORT & REMOVAL OF NON-FUNCTIONING LIFEPORT. SUCCESSFUL PERCUTANEOUS REMOVAL OF CATHETER FRAGMENT MEASURING 13.5 X 0.3 CM CATHETER NEEDED FOR CHEMOTHERAPY TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 Implant LIFEPORT STRATO MEDICAL CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 69 * Other