BEUDAMED
    FDA Adverse Event Injury Summary report: N

    *

    MDR report key: 1071553 · Received July 9, 2008

    Report

    Report Number
    MW5007555
    Event Type
    Injury
    Date Received
    July 9, 2008
    Date of Event
    June 24, 2002
    Report Date
    July 2, 2008
    Manufacturer
    I-FLOW CORP
    Product Code
    MEB
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN 2002, RT SUPERIOR LABRUM AND POSTERIOR LESION; Q PAIN PUMP USED AFTER SURGERY INTO GLENOHUMERAL AND SUBACROMIAL JOINT SPACES. MEDICATIONS WAS 300 CC OF 0.5% MARCAINE WITH EPINEPHRINE. IN 2004, RT ANTERIOR-INFERIOR INSTABILITY, BICEPS DEGENERATION; ON-Q PAIN PUMP WITH 2% LIDOCAINE WITH EPINEPHRINE, 270 CC FOR POST OP. THERE WAS NO DAMAGE TO THE ARTICULAR CARTILAGE. IN 2005, ENHANCED CT/ MR ARTHROGRAM RIGHT SHOULDER; HIGH GRADE LOSS OF THE HYALINE CARTILAGE IN THE UPPER HALF OF THE GLENOID. DOSE OR AMOUNT: 300 CC 1:200,000. ROUTE: 014. DATES OF USE: #1 2002, #2 2004. DIAGNOSIS OR REASON FOR USE: #1 RIGHT SUPERIOR LABRUM. #2 RIGHT ANTERIOR-INFERIOR INSTA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * Q PAIN PUMP MEB I-FLOW CORP * *
    2 Q PAIN PUMP MEB I-FLOW CORP

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability 300 CC OF 0.5% MARCAINE WITH EPINEPHRINE