BEUDAMED
    FDA Adverse Event Injury Summary report: N

    I-FLOW PAINBUSTER

    MDR report key: 1071562 · Received July 9, 2008

    Report

    Report Number
    MW5007564
    Event Type
    Injury
    Date Received
    July 9, 2008
    Date of Event
    February 15, 2000
    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

    ARTHROSCOPIC LEFT BANKART REPAIR; THERMAL CAPSULORRHAPHY SHIFT WITH PAIN PUMP INSERTION AFTER SURGERY. LEFT SHOULDER TOTAL SHOULDER ARTHROPLASTY IN 2007: HEALTHY MALE THAT HAS THE UNFORTUNATE SEQUELAE OF FAIRLY QUICK LOSS OF ARTICULAR CARTILAGE FOLLOWING ARTHROSCOPIC BANKHART REPAIR. IT HAS ADVANCED THROUGH LAST YEAR TO LOSS OF ALL CARTILAGE AND MARKED PAIN AND RESTRICTED MOVEMENT AND FUNCTION. DOSE OR AMOUNT: 0.5% - 120 CC, ROUTE 014. DATES OF USE: THREE DAYS IN 2000. DIAGNOSIS OR REASON FOR USE: LEFT BANKART TEAR, DIAGNOSIS OR REASON FOR USE: #2. ANTERIOR INSTABILITY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability I-FLOW PAINBUSTER WITH LOCAL 0.5% MARCAINE W/ EPI| AND MITEK THERMAL PROBE| 10 CC AT START & -100 CC| MARCAINE WITH EPINEPHRINE