BEUDAMED
    FDA Adverse Event Other Summary report: N

    ON-Q PAINBUSTER KIT

    MDR report key: 610670 · Received June 2, 2005

    Report

    Report Number
    2026095-2005-00036
    Event Type
    Other
    Date Received
    June 2, 2005
    Date of Event
    April 4, 2005
    Report Date
    May 21, 2005
    Manufacturer
    I-FLOW CORP.
    Product Code
    MEB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE PT UNDERWENT AN ARTHROSCOPIC. ACL REPAIR IN 03/05. THE PT OBSERVED REDNESS AND SWELLING AT THE CATHETER INSERTION SITE [POSTULE AT SITE] POST OPERATION DAY FOUR. ADDITIONALLY, THE CATHETER AND INFUSION PUMP WERE REMOVED ON THIS DATE. IRRIGATION AND DRAINAGE WERE PERFORMED ON THE KNEE, THE CULTURE GREW GROUP C STREP. THE PT WAS GIVEN A VARIETY OF ANTIBIOTICS AND WAS STILL RECEIVING IV ANTIBIOTICS AT HOME VIA PICC LINE. THE PT'S CONDITION WAS IMPROVING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q PAINBUSTER KIT INFUSION PUMP MEB I-FLOW CORP. PM013 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| O