BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY INC

    MDR report key: 260637 · Received January 31, 2000

    Report

    Report Number
    MW1018031
    Event Type
    Injury
    Date Received
    January 31, 2000
    Date of Event
    January 12, 2000
    Report Date
    January 24, 2000
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    KCY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WAS ADMITTED TO SURGERY FOR A RIGHT KNEE REPLACEMENT. FIVE MINS INTO THE PROCEDURE THE PROFLATE TOURNIQUET LOST PRESSURE FROM 300MM/HG TO 180 MM/HG. THE PROFLATE WAS DISCONNECTED FROM THE TUBING AND CUFF. THE TUBING AND CUFF WERE IMMEDIATELY RECONNECTED TO ANOTHER TANK TO INCREASE THE PRESSURE DURING THE PROCEDURE. NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEPUY INC PROFLATE SINGLE PUMP KCY DEPUY ORTHOPAEDICS, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention