BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PAIN PUMP PRODUCT

    MDR report key: 1364467 · Received April 14, 2009

    Report

    Report Number
    1811755-2009-00056
    Event Type
    Injury
    Date Received
    April 14, 2009
    Date of Event
    January 30, 2009
    Report Date
    March 16, 2009
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    MEB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HOSPITAL AND SURGEON NAME WERE NOT PROVIDED. THE LEAD AUTHOR IS LOCATED AT MEDICAL CENTER. THE 510(K) CANNOT BE IDENTIFIED WITHOUT INFO ON THE DEVICE USED. THE DEVICE WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    ACCORDING TO A PAPER PRESENTED AT AAOS IN 2009, 66 CASES OF CHONDROLYSIS WERE IDENTIFIED ASSOCIATED WITH SHOULDER ARTHROSCOPY FOLLOWED BY THE INTRA-ARTICULAR INFUSION OF LOCAL ANESTHETICS. NO PUMP MFR WAS IDENTIFIED IN THE PAPER. THE LEAD AUTHOR REPORTED THAT AT LEAST SOME OF THE 66 CAUSES WERE INFUSION PUMPS FROM STRYKER, SOME FROM OTHER MANUFACTURERS, AND OTHERS ARE UNK MANUFACTURERS. FURTHER INFORMATION HAS BEEN REQUESTED FROM THE LEAD AUTHOR BUT NO FURTHER INFO HAS BEEN RECEIVED. IT IS ALSO NOT KNOWN IF THESE CASES HAVE ALREADY BEEN REPORTED TO STRYKER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention