BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PAR - 1 HR REFILL, 50 ML DHR, CLOSED TIP CATHETER

    MDR report key: 192033 · Received October 7, 1998

    Report

    Report Number
    2021898-1998-00101
    Event Type
    Injury
    Date Received
    October 7, 1998
    Date of Event
    August 8, 1998
    Report Date
    August 28, 1998
    Manufacturer
    MEDTRONIC PS MEDICAL
    Product Code
    LKK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DEVICE WAS EXPLANTED AS IT WAS NO LONGER FUNCTIONING. THERE WAS BLOOD INSIDE THE DEVICE. THE PHYSICIAN COULD NOT FIND THE SOURCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PAR - 1 HR REFILL, 50 ML DHR, CLOSED TIP CATHETER Implant IMPLANTED PATIENT CONTROLLED ANALGESIA PUMP LKK MEDTRONIC PS MEDICAL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention