BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK DURASEAL DURA PRODUCT

    MDR report key: 3232256 · Received July 9, 2013

    Report

    Report Number
    1219930-2013-00524
    Event Type
    Injury
    Date Received
    July 9, 2013
    Report Date
    June 18, 2013
    Manufacturer
    COVIDIEN, FORMERLY UNITED STATES
    Product Code
    NQR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TRACKING NUMBER (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: THE SURGEON HAD A PT WHO WAS PARALYZED AND REQUIRED A RE-OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312692 UNK DURASEAL DURA PRODUCT NONE NQR COVIDIEN, FORMERLY UNITED STATES

    Patients

    Seq Age Sex Outcome Treatment
    1