BEUDAMED
    FDA Adverse Event Other Summary report: N

    SEED SELECTION

    MDR report key: 2343945 · Received November 15, 2011

    Report

    Report Number
    9611894-2011-00006
    Event Type
    Other
    Date Received
    November 15, 2011
    Date of Event
    January 27, 2009
    Report Date
    November 15, 2011
    Manufacturer
    NUCLETRON B.V.
    Product Code
    JAQ
    PMA / PMN Number
    K010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) WAS INITIATED ON (B)(4) OF 2009 TO ADDRESS CONCERNS AROUND DEMO UNIT LABELING. CORRECTIVE ACTIONS WERE TAKEN INTERNALLY TO ENSURE THAT THIS DEMO UNITS WERE PROPERLY LABELED. THIS CAPA WAS CLOSED IN (B)(4) OF 2010 AFTER THE EFFECTIVENESS CHECK WAS APPROVED. AS A RESULT OF THE FDA FORM 483 REPORT FEI NUMBER (B)(4) DATED (B)(4), 2011, NUCLETRON BV IS NOW SUBMITTING THIS MDR IN COMPLIANCE WITH THE CORRECTIVE ACTIONS OF THE FDA FORM 483.

    Description of Event or Problem · 1

    A DEMO UNIT CAME BACK FROM THE FIELD TO THE MFR, WAS NOT PROPERLY LABELED AS DEMO UNIT NOT FOR CLINICAL USE. THERE WAS NOT A SPECIFIC EVENT REPORTED ABOUT THIS UNIT, BUT WITHOUT THE PROPER LABELING THIS COULD HAVE BEEN USED IN THE FIELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEED SELECTION REMOTE CONTROLLED RADIONUCLIDE APP SYS. JAQ NUCLETRON B.V. 130001 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA