BEUDAMED
    FDA Adverse Event Other Summary report: N

    DAVOL

    MDR report key: 71068 · Received February 20, 1997

    Report

    Report Number
    71068
    Event Type
    Other
    Date Received
    February 20, 1997
    Date of Event
    February 4, 1997
    Report Date
    February 6, 1997
    Manufacturer
    DAVOL, INC.
    Product Code
    HRX
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PUMP CONTROL AND TUBING USED FOR ARTHROSCOPIC DISTENTION. INITIAL SETTING 120. DR COMPLAINED OF HAVING A DRY KNEE. AFTER REPOSITIONING THE CANNULA MANY TIMES THE PUMP SETTING WAS INCREASED TO 200. (MAX RECOMMENDED = 30). DR COMPLAINED OF EXTRAVASATION TO THE TISSUES AND STATED HE COULD NOT CONTINUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DAVOL HYDROFLEX PUMP AND TUBING HRX DAVOL, INC. 0025000 *

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other