BEUDAMED
    FDA Adverse Event Other Summary report: N

    ON-Q PAINBUSTER SOAKER

    MDR report key: 602512 · Received May 13, 2005

    Report

    Report Number
    2026095-2005-00030
    Event Type
    Other
    Date Received
    May 13, 2005
    Date of Event
    December 13, 2004
    Report Date
    May 9, 2005
    Manufacturer
    I-FLOW CORP.
    Product Code
    MEB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Description of Event or Problem · 1

    POST OPERATIVE WOUND INFECTION AFER USING 'ON Q PUMP'. FDA REPORT FURTHER STATES THAT "HOSPITALIZATION" WAS AN OUTCOME ATTRIBUTED TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q PAINBUSTER SOAKER INFUSION PUMP MEB I-FLOW CORP. PM012 412032

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization| O