BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PAIN BUSTER

    MDR report key: 1071551 · Received July 9, 2008

    Report

    Report Number
    MW5007553
    Event Type
    Injury
    Date Received
    July 9, 2008
    Date of Event
    January 3, 2002
    Report Date
    July 2, 2008
    Manufacturer
    *
    Product Code
    MEB
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN 2002, ARTHROSCOPIC SURGERY FOR RIGHT SHOULDER LABRAL TEAR/SLAP WITH ANTERIOR INSTABILITY, AND THERMAL CAPSULORRHAPHY, RIGHT SHOULDER. PAINBUSTER/CATHETER WITH 0.5% BUPIVACAINE TO SHOULDER AFTER SURGERY. THE DR NOTED: THE GLENOHUMERAL JOINT WAS FREE OF CHONDROMALACIA. IN 2006, X-RAYS TAKEN OF RT SHOULDER, AND FOUND TO HAVE MODERATE GLENOHUMERAL DEGENERATIVE JOINT DISEASE. IN 2007, X-RAYS REVEALED: RIGHT SIDE SEVERE GLENOHUMERAL JOINT SPACE NARROWING WITH POSITIVE PERIPHERAL OSTEOPHYTE SEEN AT THE INFERIOR HUMERAL HEAD AND MEDIAL INFERIOR GLENOID. DOSE OR AMOUNT: 100 CC. ROUTE: 014. DATES OF USE: 2002. DIAGNOSIS OR REASON FOR USE: RT SHOULDER LABRAL TEAR/SLAP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PAIN BUSTER PAINBUSTER PAIN PUMP MEB * * *

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability 0.5% BUPIVACAINE