BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PAIN CARE 3200

    MDR report key: 1612545 · Received February 9, 2010

    Report

    Report Number
    2028253-2010-00001
    Event Type
    Injury
    Date Received
    February 9, 2010
    Date of Event
    August 26, 2005
    Report Date
    February 5, 2010
    Manufacturer
    BREG INC.
    Product Code
    MEB
    PMA / PMN Number
    K013928
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    PT HAD MULTIPLE OUTPATIENT SHOULDER SURGERIES; (B) (6) 2005, (B) (6) 2005, (B) (6) 2006, (B) (6) 2006. A PAIN CARE 3200 WAS USED DURING THE FIRST SURGERY. AN I-FLOW ON-Q WAS USED FOR THE (B) (6) 2006 SURGERY. PT NOW ALLEGES THAT SHE HAS GLENHUMERAL CHONDROLYSIS IN THIS SHOULDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PAIN CARE 3200 INFUSION PUMP MEB BREG INC. PAIN CARE 3200 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Disability