BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PAIN CARE 4200

    MDR report key: 2142361 · Received June 20, 2011

    Report

    Report Number
    2028253-2011-00027
    Event Type
    Injury
    Date Received
    June 20, 2011
    Date of Event
    March 4, 2004
    Report Date
    June 17, 2011
    Manufacturer
    BREG, INC
    Product Code
    FRN
    PMA / PMN Number
    K020988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    BREG RECEIVED LEGAL NOTICE OF FILED LAWSUIT WITH USE OF PAIN CARE 4200. PT HAD L ANKLE SURGERY AND ALLEGES DEGENERATIVE CARTILAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PAIN CARE 4200 88 FRN FRN BREG, INC PAIN CARE UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| S