BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSAID IMPLANTABLE INFUSION PUMP

    MDR report key: 87279 · Received April 25, 1997

    Report

    Report Number
    1219454-1997-00203
    Event Type
    Injury
    Date Received
    April 25, 1997
    Date of Event
    December 5, 1996
    Report Date
    April 1, 1997
    Manufacturer
    STRATO/INFUSAID, INC.
    Product Code
    MDY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON 4/14/97, THE MFR RECEIVED THE ATTACHED MEDWATCH REPORT #1011084 FROM THE FDA, MEDWATCH MEDICAL PRODUCTS REPORTING PROGRAM. THE REPORT STATES THAT ON 12/5/96 IT WAS DISCOVERED THAT THE PT'S DEVICE HAD AN INCREASED DAILY FLOW RATE THAN ORIGINALLY CALIBRATED. THE PT WILL GET THE SAME DOSE OF FUDR DELIVERED OVER 12.7 DAYS RATHER THAN 14 DAYS, AND THE DEVICE WILL HAVE TO BE REFILLED MORE OFTEN. THE OTHER ALTERNATIVE IS TO TAKE THE PT BACK TO THE OR AND REPLACE THE PUMP.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention