BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DURASEAL SPINE SEALANT 2ML XTA

    MDR report key: 2512327 · Received March 14, 2012

    Report

    Report Number
    1219930-2012-00134
    Event Type
    Malfunction
    Date Received
    March 14, 2012
    Date of Event
    December 31, 2011
    Report Date
    February 13, 2012
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    NQR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: THE PT EXPERIENCED AN ENTEROCUTANEOUS FISTULA. ONGOING. RELATIONSHIP TO DEVICE, POSSIBLE RELATIONSHIP. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DURASEAL SPINE SEALANT 2ML XTA DURASEAL SPINE SEALANT NQR UNITED STATES SURGICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR