BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK DURASEAL PRODUCT

    MDR report key: 3911588 · Received June 27, 2014

    Report

    Report Number
    1219930-2014-00485
    Event Type
    Injury
    Date Received
    June 27, 2014
    Report Date
    May 30, 2014
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL
    Product Code
    NQR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    TRACKING NUMBER (B)(4). DATE OF INITIAL REPORT SENT: 06/27/2014.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: CASE INVOLVES DURASEAL AND REPAIR OF CSF LEAK, PT NOW HAS SOME PARALYSIS. REQUESTS FOR ADDITIONAL INFO HAVE BEEN ANSWERED WITH NOTHING FURTHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376282 UNK DURASEAL PRODUCT DURASEAL NQR COVIDIEN, FORMERLY US SURGICAL UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other