BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PAINPUMP PRODUCT

    MDR report key: 1113168 · Received August 12, 2008

    Report

    Report Number
    1811755-2008-00041
    Event Type
    Injury
    Date Received
    August 12, 2008
    Date of Event
    July 1, 2005
    Report Date
    July 15, 2008
    Manufacturer
    STRYKER INSTRUMENTS, KALAMAZOO
    Product Code
    MEB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVAL.

    Description of Event or Problem · 1

    PER COURT DOCUMENT REC'D, PT UNDERWENT ARTHROSCOPIC SHOULDER SURGERY IN 2005, AND A PAINPUMP WAS PLACED IN HIS SHOULDER JOINT FOR POST OPERATIVE PAIN RELIEF. THE PT NOW ALLEGES HE HAS CHONDROLYSIS. IN 2008, THE PT UNDERWENT PARTIAL SHOULDER REPLACEMENT SURGERY AND MAY REQUIRE ADD'L SURGERY, INCLUDING A COMPLETE SHOULDER REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN PAINPUMP PRODUCT INFUSION PUMP MEB STRYKER INSTRUMENTS, KALAMAZOO UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention