BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PAIN CARE 4200

    MDR report key: 1657868 · Received April 7, 2010

    Report

    Report Number
    MW5015505
    Event Type
    Injury
    Date Received
    April 7, 2010
    Date of Event
    March 3, 2005
    Report Date
    April 7, 2010
    Manufacturer
    BREG, INC.
    Product Code
    MEB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B) (6) 2005 HAD ARTHROSCOPIC REPAIR OF BANKART LESION FOR INJURY SUFFERED DURING A HIGH-SCHOOL BASKETBALL GAME ON (B) (6) 2005. HAD MRI ON (B) (6) 2005. BREG PAIN CARE 4200 WITH MARCAINE WAS PLACED IN THE INTRA-ARTICULAR SPACE OF RIGHT SHOULDER AND USED FOR 4 DAYS FROM (B) (6) 2005-(B) (6) 2005. IT WAS REMOVED BY THE HEALTH-CARE PROVIDER. PT WAS TOLD TO LEAVE DEVICE ALONE AND AT NO POINT DID PT OR HER CAREGIVER MAKE ANY ADJUSTMENTS TO THE PAIN PUMP. INITIAL RECOVERY AND PHYSICAL THERAPY WAS UNEVENTFUL AND PROGNOSIS WAS DESCRIBED AS EXCELLENT. PAIN IN SHOULDER VERY NOTICEABLE IN 2006. TRIED TO PLAY COLLEGE BASKETBALL IN 2007. IN 2007, HAD MRI WHICH REVEALED NEAR-END STAGE CHONDROLYSIS OF RIGHT SHOULDER. WAS TOLD SHE WOULD MULTIPLE TOTAL SHOULDER REPLACEMENTS IN HER LIFETIME, BUT TO "HOLD ONTO" THE JOINT AS LONG AS PHYSICALLY POSSIBLE. WE ARE INVOLVED IN LITIGATION WITH BREG, INC. DOSE OR AMOUNT: MARCAINE, ROUTE: INTRA-ARTICULAR. DATES OF USE: (B) (6) 2005-(B) (6) 2005. DIAGNOSIS: PAIN CONTROL AFTER ARTHROSCOPIC SHOULDER SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PAIN CARE 4200 PAIN PUMP MEB BREG, INC. PAIN CARE 4200

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Required Intervention