BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRAWAND LP

    MDR report key: 1961590 · Received December 27, 2010

    Report

    Report Number
    3003870001-2010-00015
    Event Type
    Malfunction
    Date Received
    December 27, 2010
    Report Date
    December 1, 2010
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    NTB
    PMA / PMN Number
    K080292
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WE ARE IN THE PROCESS OF EVALUATING THIS DEVICE. WHEN OUR INVESTIGATION IS COMPLETE, A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE WAS POPPING AND HISSING DURING USE. THERE WERE NO REPORTED PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRAWAND LP ULTRAWAND LP NTB ST. JUDE MEDICAL 12400 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK