BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N/A

    MDR report key: 1811617 · Received August 23, 2010

    Report

    Report Number
    2090040-2010-00007
    Event Type
    Malfunction
    Date Received
    August 23, 2010
    Date of Event
    July 26, 2010
    Report Date
    August 23, 2010
    Product Code
    FAD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ASCENT RESTERILIZED THE COMPLAINT DEVICE THROUGH OUR OPEN-BUT-UNUSED PROCESS. ONLY THE DEVICE LABELING AND NOT THE DEVICE ITSELF WAS RETURNED TO ASCENT FOR EVALUATION. IT WAS CONFIRMED THAT THE OEM LABEL STATED THE DEVICE WAS A 4.7 FRENCH WITH A LENGTH OF 22 CENTIMETERS AND THE ASCENT LABEL STATED THE DEVICE WAS A 6 FRENCH WITH A LENGTH OF 22 CENTIMETERS. AS PART OF THE INVESTIGATION A MEASURE OF THE ABILITY FOR THE CURRENT PROCESS TO ACCURATELY IDENTIFY AND LABEL OPEN-BUT-UNUSED PRODUCT WAS CONDUCTED. THIS INCLUDED A SAMPLE SIZE OF 38 IMPLANTABLE DEVICES. ALL DEVICES WERE INSPECTED AFTER BEING LABELED TO VERIFY EQUIVALENCY BETWEEN THE ASCENT LABEL AND THE OEM LABEL. THIS APPEARS TO BE AN ISOLATED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A URETERAL STENT WAS INCORRECTLY LABELED AND INPLANTED IN A PATIENT. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 N/A FAD FAD 778622

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR