BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PAIN CARE 3000

    MDR report key: 1612543 · Received February 9, 2010

    Report

    Report Number
    2028253-2010-00002
    Event Type
    Injury
    Date Received
    February 9, 2010
    Date of Event
    July 23, 2003
    Report Date
    February 5, 2010
    Manufacturer
    BREG INC.
    Product Code
    MEB
    PMA / PMN Number
    K002073
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    PT HAD 2 SHOULDER SURGERIES. FIRST WAS ON (B) (6) 2003 FOR THE RIGHT SHOULDER. A PAIN CARE 3000 WAS USED. ON (B) (6) 2004 A SECOND SURGERY WAS PERFORMED ON THE LEFT SHOULDER AND AGAIN A PAIN CARE 3000 WAS USED. PT NOW ALLEGES THAT SHE HAS GLENHUMERAL CHONDROLYSIS IN THE SHOULDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PAIN CARE 3000 INFUSION PUMP MEB BREG INC. PAIN CARE 3000 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability