BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2-DAY INFUSION KIT

    MDR report key: 1001934 · Received February 18, 2008

    Report

    Report Number
    1811755-2008-00007
    Event Type
    Injury
    Date Received
    February 18, 2008
    Date of Event
    March 7, 2005
    Report Date
    January 30, 2008
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    MEB
    PMA / PMN Number
    K042405
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE COURT DOCUMENT, IT IS NOT KNOWN IF A STRYKER PAINPUMP OR AN I-FLOW PAINPUMP WAS UTILIZED ON THIS PT. THE DEVICE WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    PT ALLEGES LOSS OF CARTILAGE IN HIS SHOULDER RESULTING IN SEVERE PAIN AND LOSS OF USE AND FUNCTION. PT ALLEGES THAT THE USE OF A PAINPUMP WAS A CONTRIBUTING FACTOR IN CAUSING THESE INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2-DAY INFUSION KIT INFUSION PUMP MEB STRYKER INSTRUMENTS KALAMAZOO UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR Required Intervention