BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPLY

    MDR report key: 3181451 · Received June 14, 2013

    Report

    Report Number
    1000165971-2013-00297
    Event Type
    Injury
    Date Received
    June 14, 2013
    Date of Event
    May 22, 2013
    Report Date
    June 4, 2013
    Manufacturer
    SORIN GROUP ITALIA S.R.L.
    Product Code
    NVZ
    PMA / PMN Number
    P950029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6), 2013. THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE THE UNITED STATES. ANALYSIS IS PENDING.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271528 REPLY NVZ SORIN GROUP ITALIA S.R.L. REPLY DR 2404

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention