BEUDAMED
    FDA Adverse Event Injury Summary report: N

    I-FLOW ON-Q PAINBUSTER

    MDR report key: 1071554 · Received July 9, 2008

    Report

    Report Number
    MW5007556
    Event Type
    Injury
    Date Received
    July 9, 2008
    Date of Event
    September 24, 2004
    Report Date
    July 2, 2008
    Manufacturer
    I-FLOW
    Product Code
    MEB
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON 09/24/04 ARTHROSCOPIC RT. SHOULDER; POST OP DIAGNOSIS: RIGHT SUPERIOR LABRAL TEAR, POSTERIOR BICEPS TEAR, INFERIOR INSTABILITY. ON 09/29/04: ADDITIONAL 50 CC OF LIDOCAINE W/EPINEPHRINE TO PAIN PUMP; ALSO FLUSHED THE LINE W/ ABOUT 5 CC OF LIDOCAINE. ON 9/13/05: MRI FINDINGS: THERE IS VIRTUALLY NO HYALINE CARTILAGE LEFT IN THE GLENOID FOSSA IN AN AREA THAT CONSTITUTES ROUGHLY 2/3 OF ITS SURFACE AND CARTILAGE IS WORN OFF A LARGE AREA OF THE HUMERAL HEAD LEAVING ESSENTIALLY BONE-ON-BONE CONTACT. CURRENT DOCTOR NOTED: PT MAY VERY WELL NEED A JOINT ARTHROPLASTY IN FUTURE, ALTHOUGH IS CERTAINLY TOO YOUNG AND ACTIVE TO CONSIDER THIS AT THIS TIME. DOSE OR AMOUNT: 270 ML. FREQUENCY: 5 ML/HR. ROUTE: 014. DIAGNOSIS OR REASON FOR USE: RIGHT SHOULDER SLAP REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 I-FLOW ON-Q PAINBUSTER ON-Q PAINBUSTER MEB I-FLOW 472104

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Disability LIDOCAINE W/ EPINEPHRINE 2%. - 270 ML