BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2-DAY INFUSION KIT

    MDR report key: 1772177 · Received July 16, 2010

    Report

    Report Number
    1811755-2010-00796
    Event Type
    Injury
    Date Received
    July 16, 2010
    Date of Event
    November 1, 2002
    Report Date
    June 29, 2010
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    MEB
    PMA / PMN Number
    K042405
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE LOT NUMBER WAS NOT PROVIDED. THERE IS NO ALLEGED FAILURE OF THE PUMP AND THE DEVICE HAS NOT BEEN RETURNED FOR EVAL. DESIGN, MECHANICAL AND MFG ELEMENTS RELATING TO THE FUNCTION OF THE PUMP CANNOT BE DETERMINED. NO DATA PRESENTLY SUGGESTS A DIRECT LINK BETWEEN ANY INHERENT ASPECT OF FEATURE OF THE PUMP AND THE DEVELOPMENT OF CHONDROLYSIS. ALTHOUGH THERE IS NO RANDOMIZED CLINICAL DATA ASSOCIATED WITH THE USE OF LOCAL ANESTHETICS (WITH OR WITHOUT EPI) AND THE DEVELOPMENT OF CHONDROLYSIS, RECENT CASE REPORTS, ANIMAL, AND IN-VITRO STUDIES SUGGEST A POSSIBLE CONNECTION. THE USE OF THERMAL/RF DEVICES, VARIOUS DYES AND SOLUTIONS MECHANICAL INJURY TO CARTILAGE, OSMOLARITY, BIODEGRADABLE SUTURES, SUB-CLINICAL INFECTION, AGE SURGICAL INTERVENTION, OVER TIGHTENED JOINTS AND VARIOUS OTHER PHYSICIAN/PATIENT FACTORS HAVE ALSO BEEN REPORTED AS POTENTIALLY CONTRIBUTING TO OR CAUSING CHONDROLYSIS. THE ETIOLOGY OF THE CONDITION REMAINS UNKNOWN AND BELIEVED TO BE MULTI-FACTORIAL. CURRENT LABELING FOR THIS PRODUCT ADVISES ABOUT REPORTS OF A POSSIBLE CONNECTION BETWEEN LOCAL ANESTHETICS (WITH OR WITHOUT EPI) AND CHONDROLYSIS IN CERTAIN CIRCUMSTANCES.

    Description of Event or Problem · 1

    ON OR ABOUT (B)(6), 2010, STRYKER RECEIVED A PERSONAL INJURY LAWSUIT ALLEGING THAT A PATIENT WAS PRESCRIBED A STRYKER PAINPUMP FOLLOWING SHOULDER SURGERY ON (B)(6), 2002. THE PATIENT WAS DIAGNOSED WITH CHONDROLYSIS AND ALLEGES THE CHONDROLYSIS IS A RESULT OF THE CONTINUED INJECTION OF MEDICATION IN TO THEIR SHOULDER. THERE ARE NO ALLEGATIONS THE PRODUCT FAILED TO PERFORM AS DESIGNED OR PROGRAMMED BY THE PHYSICIAN. STRYKER IS UNABLE TO ASCERTAIN WHETHER OR NOT ONE OF ITS PRODUCTS WAS ACTUALLY USED AND WILL NOT BE ABLE TO OBTAIN THE PRODUCT EXCEPT WITHIN THE LITIGATION PROCESS, IF AT ALL.

    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 Required Intervention