BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PAIN CARE 3000

    MDR report key: 1729761 · Received June 8, 2010

    Report

    Report Number
    2028253-2010-00014
    Event Type
    Injury
    Date Received
    June 8, 2010
    Date of Event
    October 10, 2003
    Report Date
    June 7, 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 L SHOULDER ARTHROSCOPIC SURGERY ON (B) (6) 2003. CLAIM INDICATES THAT BREG PAIN PUMP WAS USED. PT ALLEGES GLENOHUMERAL CHONDROLYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PAIN CARE 3000 88MRB MEB BREG, INC. 10314 13135959

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Disability