BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING¿

    MDR report key: 2872881 · Received December 13, 2012

    Report

    Report Number
    2134265-2012-07973
    Event Type
    Malfunction
    Date Received
    December 13, 2012
    Date of Event
    October 12, 2012
    Report Date
    November 30, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DQY
    PMA / PMN Number
    K053116
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERLING¿ CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC - MAPLE GROVE H74939032604080 15423437

    Patients

    Seq Age Sex Outcome Treatment
    1 V-18 GUIDE WIRE