BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK DURASEAL PRODUCT

    MDR report key: 3964900 · Received July 18, 2014

    Report

    Report Number
    1219930-2014-00549
    Event Type
    Injury
    Date Received
    July 18, 2014
    Report Date
    June 18, 2014
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL
    Product Code
    NQR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: NEURO SURGERY, SPECIFICALLY, FORAMEN MAGNUM DECOMPRESSION. LITERATURE REVIEW: ACCORDING TO THE AUTHORS OF THE ARTICLE " POSTOPERATIVE CERVICAL CORD COMPRESSION INDUCED BY HYDROGEL DURAL SEALANT" THERE WAS A CASE REPORTED OF A (B)(6) FEMALE WHO DEVELOPED WORSENING QUADRIPARESIS DUE TO THE MASS EFFECT OF HYDROGEL SEALANT ON THE CERVICOMEDULLARY REGION POST SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423439 UNK DURASEAL PRODUCT HYDROGEL SEALANT NQR COVIDIEN, FORMERLY US SURGICAL NOT AVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Required Intervention