BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PAIN PUMP PRODUCT

    MDR report key: 2042192 · Received March 28, 2011

    Report

    Report Number
    1811755-2011-00984
    Event Type
    Injury
    Date Received
    March 28, 2011
    Date of Event
    January 16, 2008
    Report Date
    July 13, 2010
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    MEB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE 510(K) CANNOT BE IDENTIFIED WITHOUT INFORMATION ON THE DEVICE USED. THERE IS NO ALLEGED FAILURE OF THE PUMP AND THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. 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 OR 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 W/O 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/PT FACTORS HAVE ALSO BEEN REPORTED AS POTENTIALLY CONTRIBUTING TO OR CAUSING CHONDROLYSIS. THE ETIOLOGY OF THE CONDITION REMAINS UNK AND BELIEVED TO BE MULTI-FACTORIAL. CURRENT LABELING FOR THIS PRODUCT ADVISES ABOUT REPORTS OF A POSSIBLE CONNECTION BETWEEN LOCAL ANESTHETICS (WITH OR W/O EPI) AND CHONDROLYSIS IN CERTAIN CIRCUMSTANCES.

    Description of Event or Problem · 1

    ON OR ABOUT (B)(6) 2010, STRYKER REC'D A PERSONAL INJURY LAWSUIT ALLEGING THAT A PT WAS PRESCRIBED A STRYKER PAINPUMP AFTER AT LEAST ONE OF TWO SHOULDER SURGERIES ON (B)(6) 2008, (B)(6) 2008. THE PT ALLEGED CHONDROLYSIS AS A RESULT OF THE CONTIN. INJECTION OF MEDICATION INTO 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. ON (B)(6) 2011, STRYKER WAS NOTIFIED THAT THE LAWSUIT WAS VOLUNTARILY DISMISSED. IT WAS NOT/CANNOT BE DETERMINED WHERE THE CATHETER WAS PLACED AND IF THE USE OF THE PAIN PUMP CAUSED INJURIES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention