BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PAIN CARE 3000

    MDR report key: 2111797 · Received May 25, 2011

    Report

    Report Number
    2028253-2011-00023
    Event Type
    Injury
    Date Received
    May 25, 2011
    Date of Event
    February 28, 2007
    Report Date
    May 24, 2011
    Manufacturer
    BREG, INC.
    Product Code
    FRN
    PMA / PMN Number
    K002073
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    BREG REC'D LEGAL NOTICE OF FILED LAWSUIT WITH USE OF PAIN CARE PRODUCT. PT HAD LEFT SHOULDER SURGERY ON (B)(6) 2007 AND ALLEGES THAT BREG PAIN PUMP WAS USED. PT NOW ALLEGES GLENHUMERAL CHONDROLYSIS AND DEGENERATION OF CARTILAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PAIN CARE 3000 88 FRN FRN BREG, INC. 10314 27701791

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| S