BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PAIN CARE 3000

    MDR report key: 1696167 · Received May 18, 2010

    Report

    Report Number
    2028253-2010-00009
    Event Type
    Injury
    Date Received
    May 18, 2010
    Date of Event
    July 1, 2004
    Report Date
    April 14, 2010
    Manufacturer
    BREG, INC.
    Product Code
    FRN
    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

    PATIENT WAS INJURED DURING A (B) (6) CHEERLEADING ACCIDENT IN 2004. SUBSEQUENTLY, MD PERFORMED AN ARTHROSCOPIC SLAP LABRAL REPAIR ON (B) (6) 2004. THE BREG PAIN CARE 3000 WAS USED POST-OP AFTER THE 2004 SURGERY. PATIENT IS NOW ALLEGING GLENOHUMERAL CHONDROLYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PAIN CARE 3000 88 FRN FRN BREG, INC. PAIN CARE 3000 24177554

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Disability