BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DURASEAL PRODUCT

    MDR report key: 3964899 · Received July 18, 2014

    Report

    Report Number
    1219930-2014-00548
    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: EXCISION OF SPINAL MENINGIOMA. LITERATURE REVIEW: ACCORDING TO THE AUTHORS OF THE ARTICLE "POSTOPERATIVE CERVICAL CORD COMPRESSION INDUCED BY HYDROGEL DURAL SEALANT" THERE WAS A CASE REPORTED THAT WHILE REPAIRING THE PATIENT'S DURA, DURASEAL WAS APPLIED TO THE DURAL SURFACE BECAUSE, THE DURA WAS INCOMPLETELY APPROXIMATED WITH SUTURES. EIGHT HOURS AFTER SURGERY, THE PATIENT DEVELOPED LEFT SIDED WEAKNESS. MRI REVEALED LARGE EXTRADURAL MASS CAUSING CORD COMPRESSION AT THE LEVEL OF THE TUMOR REMOVAL. EMERGENT WOUND EXPLORATION AND RE-OPERATION OF THE WOUND REVEALED A THICK LAYER OF GELATINOUS MATERIAL CONSISTENT WITH DURASEAL. THE LAYER OF HYDROGEL COMPRESSED THE DURAL SAC SEVERELY. THE HYDROGEL COMPRESSED THE DURAL SAC SEVERELY. THE HYDROGEL LAYER WAS EXCISED. AFTER SURGERY THE PATIENT'S CONDITION IMPROVED FROM MOTOR GRADE I TO MOTOR GRADE II.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423427 UNKNOWN DURASEAL PRODUCT HYDROGEL SEALANT NQR COVIDIEN, FORMERLY US SURGICAL UNK DURASEAL NOT AVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention