BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSAID IMPLANTABLE INFUSION PUMP

    MDR report key: 35779 · Received July 1, 1996

    Report

    Report Number
    35779
    Event Type
    Malfunction
    Date Received
    July 1, 1996
    Date of Event
    March 20, 1996
    Report Date
    March 29, 1996
    Manufacturer
    STRATO/INFUSAID, INC.
    Product Code
    LKK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    DC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PUMP WAS IMPLANTED ON 2/15/96. MALFUNCTION. THE MAIN CHAMBER WOULD NOT DISPENSE FLUID AND THE SIDE PORT WOULD NOT WORK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSAID IMPLANTABLE INFUSION PUMP Implant IMPLANTABLE INFUSION PUMP LKK STRATO/INFUSAID, INC. 400 *

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other