BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ON-Q PAIN MANAGEMENT SYSTEM

    MDR report key: 414994 · Received September 4, 2002

    Report

    Report Number
    2026095-2002-00013
    Event Type
    Injury
    Date Received
    September 4, 2002
    Date of Event
    March 29, 2001
    Report Date
    August 30, 2002
    Manufacturer
    I-FLOW CORP.
    Product Code
    FRN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    IN RESPONSE TO MEDWATCH 1023092. IT WAS REPORTED THAT THE USE OF THE ON-Q LOCAL ANESTHETIC DELIVERY SYSTEM IN A PT UNDERGOING FEMORAL POPLITEAL BYPASS SURGERY ASSOCIATED WITH LARGE FULL THICKNESS SKIN NECROSIS OF GROIN WOUND. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, I-FLOW, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q PAIN MANAGEMENT SYSTEM INFUSION PUMP FRN I-FLOW CORP. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1