BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENCORE

    MDR report key: 399117 · Received June 11, 2002

    Report

    Report Number
    MW1025267
    Event Type
    Malfunction
    Date Received
    June 11, 2002
    Date of Event
    April 1, 2002
    Report Date
    June 11, 2002
    Manufacturer
    ENCORE
    Product Code
    FYH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    RPTR RECEIVED AN INCORRECT AND INFERIOR PRODUCT IN A BOX WITH THE SAME CATALOG # AS BEFORE, BUT THE PRODUCT IS A DIFFERENT ONE. THE CO KEPT THE SAME CAT # BUT KEEPS PUTTING A DIFFERENT AND INFERIOR PRODUCT IN THAT SAME BOX. THIS HAS BEEN BROUGHT TO THEIR ATTENTION 4 TIMES.

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 8/20/02: ENCORE MEDICAL, L.P. SOFT GOODS DIVISION WAS UNABLE TO CONTACT THE DEVICE OPERATOR (END USER) TO UNDERSTAND THE EVENT ON THE MDR REPORT, BUT COMPLETED AN INVESTIGATION ON THE INCIDENT STATED ON MEDICAL DEVICE REPORT NUMBER MW1025267, SPLINT, EXTREMITY, NONINFLATABLE, EXTERNAL AND HAS CONCLUDED THAT THE INCIDENT SHOULD NOT BE WARRANTED AS AN MDR REPORTABLE-EVENT, WHERE THERE WAS NO INDICATION OF A SIGNIFICANT MEDICAL DEVICE ADVERSE EVENT OR PRODUCT PROBLEM. ENCORE'S INVESTIGATION CONCLUDED THAT THERE ARE TWO OUTSOURCING SUPPLIERS FOR THIS PRODUCT (KNEE IMMOBILIZER, ITEM # 00229) AND THE PRODUCT DOES MEET ALL ENCORE'S SPECS AND ITS FUNCTIONALITY. ALSO, ENCORE RECENTLY INQUIRED THIS PRODUCT AND OTHERS FROM KIMBERLY-CLARK SOFT GOODS LINE INCLUDING THEIR ENTIRE INVENTORY THAT MIGHT HAVE CONFUSED THE END USER ON THIS POSSIBILITY. DUE TO THE FACT THAT THIS INCIDENT DOES NOT CONSTITUTE OR SHOULD HAVE NOT BEEN CONSIDERED AS AN MDR REPORTABLE-EVENT, ENCORE IS REQUESTING FOR THE FDA TO REMOVE THE REPORT FROM ANY FDA DOCUMENTATION AND/OR MEDICAL DEVICE REPORTING WEBSITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENCORE KNEE IMMOBILIZER FYH ENCORE * ENC 303

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other