BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BREG

    MDR report key: 1071573 · Received July 9, 2008

    Report

    Report Number
    MW5007574
    Event Type
    Injury
    Date Received
    July 9, 2008
    Date of Event
    June 24, 2004
    Report Date
    July 2, 2008
    Manufacturer
    BREG, INC.
    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 2004- LEFT SHOULDER ARTHROSCOPIC ANTERIOR CAPSULAR PLICATION, ACROMIOPLASTY AND PAIN PUMP PLACEMENT IN LEFT SHOULDER GLENOHUMERAL SPACE. APPROX FOUR MONTHS LATER, RIGHT SHOULDER CAPSULAR PLICATION AND ARTHROSCOPIC ACROMIOPLASTY W/ ON-Q PAIN BUSTER PAIN PUMP PLACED IN THE GLENOHUMERAL SPACE. IN EARLY 2008- TRYING TO GET INSURANCE APPROVAL FOR LEFT TOTAL SHOULDER REPLACEMENT. IN 2004- LEFT- BREG PAIN PUMP PLACED. APPROX FOUR MONTHS LATER- RT-ON-Q PAIN BUSTER. DOSE OR AMOUNT: 150ML, 270 ML. FREQUENCY: UNK, 5ML/HR. ROUTE:014, 014. DATES OF USE: 2004. DIAGNOSIS OR REASON FOR USE:INSTABILITY, IMPINGEMENT LEFT. RIGHT GLENOHUMERAL INSTABILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BREG BREG PAIN PUMP MEB BREG, INC. UNK UNK
    2 I-FLOW RIGHT ON-Q PAIN BUSTER MEB I-FLOW CORP I-FLOW REF PM014 I-FLOW LOT# 472104

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability LEFT- 2% XYLOCAINE W/ EPINEPHRINE 1:100| RIGHT- LIDOCAINE 2% W/ EPINEPHRINE