BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PAIN CARE 2000

    MDR report key: 1033820 · Received April 24, 2008

    Report

    Report Number
    2028253-2008-00001
    Event Type
    Injury
    Date Received
    April 24, 2008
    Date of Event
    March 26, 2004
    Report Date
    April 17, 2008
    Manufacturer
    BREG, INC.
    Product Code
    MEB
    PMA / PMN Number
    K983454
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    PT DL UNDERWENT AN OPEN REPAIR OF THE ROTATOR CUFF AND ACROMIOPLASTY OF THE RIGHT SHOULDER. FOLLOWING THE SURGERY, A PAIN CARE 2000 WAS APPLIED BY HIS SURGEON, DR. AT SURGICAL CENTER. AS ALLEGED IN THE COMPLAINT, THE PT CLAIMS TO HAVE SUFFERED A NARROWING OF THE JOINT SPACE AND A CONDITION CALLED "GLENOHUMERAL CHONDROLYSIS," WHICH IS DESCRIBED AS THE COMPLETE OR NEARLY COMPLETE LOSS OF CARTILAGE IN THE SHOULDER JOINT, AN IRREVERSIBLE, DISABLING AND PAINFUL CONDITION. THE COMPLAINT ALSO ALLEGES THAT THE CONTINUOUS INJECTION OF MEDICATIONS OVER TIME DIRECTLY INTO THE SHOULDER JOINT, ROUTINELY CAUSES SERIOUS AND PERMANENT DAMAGE TO THE CARTILAGE OF THE SHOULDER JOINT. AT THIS TIME, THERE IS NO INFO AVAILABLE ABOUT THE PT'S MEDICAL HISTORY OR CONDITION, EITHER PRE-EXISTING OR POST OPERATIVE, THE DETAILS OF THE SURGICAL PROCEDURE, THE MEDICATION, DOSAGE OR INSTRUCTION. THE EXACT UNIT HAS NOT BEEN IDENTIFIED EXCEPT THAT IT WAS A PAIN CARE 2000 WHICH HE ALLEGEDLY USED FOR 48 HOURS POST SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PAIN CARE 2000 INFUSION PUMP MEB BREG, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Disability SUCH INFO WILL NOT BE AVAILABLE UNTIL FORMAL| DISCOVERY HAS TAKEN PLACE.| NO INFO WAS PROVIDED BY THE INITAL REPORTER .