BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PAIN CARE 3200

    MDR report key: 2912200 · Received January 11, 2013

    Report

    Report Number
    2028253-2013-00002
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    March 27, 2006
    Report Date
    December 17, 2012
    Manufacturer
    BREG, INC.
    Product Code
    MEB
    PMA / PMN Number
    K002073
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    ON (B)(4) 2012, BREG, INC. WAS NOTIFIED BY BOWMAN AND (B)(4) OF A PENDING LEGAL ACTION INVOLVING THE PAIN CARE PRODUCT. THE PATIENT HAD SURGERY ON HIS RIGHT SHOULDER ON (B)(6) 2006 AND ALLEGES THAT THE PHYSICIAN INSERTED A CATHETER INTO HIS SHOULDER FOLLOWING SURGERY. THE PATIENT NOW ALLEGES THAT THE DEVICE CAUSED CHONDROLYSIS AND DEGENERATION OF HIS RIGHT SHOULDER. NO ADDITIONAL INFORMATION REGARDING THE PATIENT OR NATURE OF THE INJURIES WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16517 PAIN CARE 3200 PAIN CARE 3200 MEB BREG, INC. 3200 26557872

    Patients

    Seq Age Sex Outcome Treatment
    1 Other