BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EPAIN CARE

    MDR report key: 1701021 · Received May 24, 2010

    Report

    Report Number
    2028253-2010-00010
    Event Type
    Injury
    Date Received
    May 24, 2010
    Date of Event
    January 18, 2006
    Report Date
    May 20, 2010
    Manufacturer
    BREG, INC.
    Product Code
    FRN
    PMA / PMN Number
    K041714
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    PLAINTIFF UNDERWENT AN ACL REPAIR ON (B) (6) 2006. PLAINTIFF'S SURGICAL RECORDS INDICATE, SHE USED A 200 CC PUMP AT AN INFUSION RATE OF 2 CC PER HOUR. DR'S NOTES FURTHER INDICATE, AN E-PAINCARE WAS USED. PT IS NOW CLAIMING GLENOHUMERAL CHONDROLYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EPAIN CARE 88FRN FRN BREG, INC. 15021 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Disability