BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ON-Q PAIN MANAGEMENT SYSTEM

    MDR report key: 341650 · Received July 9, 2001

    Report

    Report Number
    2026095-2001-00009
    Event Type
    Injury
    Date Received
    July 9, 2001
    Date of Event
    May 2, 2001
    Report Date
    July 2, 2001
    Manufacturer
    I-FLOW CORPORATION
    Product Code
    MEB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT A SIGMOID COLECTOMY IN 2001 FOR COLONIC STRICTURE. THE ON-Q WAS IMPLEMENTED TO MANAGE POST-OP PAIN IN 2001, PRESENTED WOUND INFECTION ACCOMPANIED OF PAIN AT THE RIGHT SIDE OF INCISION. INCISION WAS OPENED AND WOUND CLEANED OUT AND PACKED (ON-Q) REMOVED IN 2001. THE SURGEON CONSIDERED THIS EVENT POSSIBLY RELATED TO THE ON-Q DEVICE. THE PT WAS DISCHARGED FROM THE HOSPITAL ON THE 7TH DAY POST-OP AND AS OF 05/23/2001 THE RESOLUTION OF THE EVENT WAS UNKNOWN. THE PT REQUIRED INCISION TO BE REOPENED. A CT SCAN PERFORMED DUE TO CONTINUE PAIN AND PROLONGED HOSPITALIZATION.

    Description of Event or Problem · 2

    PT UNDERWENT AN EXPLORATORY LAPAROTOMY, LYSIS OF ADHESION FOR SMALL BOWEL OBSTRUCTION. THE ON-Q WAS IMPLEMENTED TO MANAGE POST-OP PAIN. IN 2001, PRESENTED POST-OP WOUND INFECTION (PSEUDOMONAS) ACCOMPANIED OF PAIN IN WOUND. WOUND DEVELOPED THE PHYSICIAL APPEARANCE OF NECROTIC EDGES WITH SPREADING CELLILITIES. THE SURGEON CONSIDERED THIS EVENT POSSIBLY RELATED TO THE ON-Q DEVICE. THE PT WAS DISCHARGED FROM THE HOSPITAL IN 2001; AND AS OF 05/23/2001 THE RESOLUTION OF EVENT WAS UNKNOWN. THE PT REQUIRED SURGICAL DEBRIDEMENT AND EXPLORATION, MEDICATION AND PROLONGED HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30905 ON-Q PAIN MANAGEMENT SYSTEM PAIN MANAGEMENT INFUSION SYSTEM MEB I-FLOW CORPORATION NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization
    2 81 YR Hospitalization