BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DURASEAL PRODUCT

    MDR report key: 2250022 · Received September 9, 2011

    Report

    Report Number
    3003157248-2011-00010
    Event Type
    Injury
    Date Received
    September 9, 2011
    Date of Event
    September 27, 2010
    Report Date
    August 8, 2011
    Manufacturer
    CONFLUENT
    Product Code
    NQR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: SPINAL SURGERY. ACCORDING TO THE REPORTER: SOME OF THE PRODUCT HAD EXPANDED IN HER LOWER 1/2 OF HER BODY. THE PATIENT HAD A REOPERATION THAT HAS LEFT HER UNABLE TO USE HER BLADDER WITH OUT A SHUNT. HER SURGERY WAS FOR THE L3, 4, 5HE. IT WAS ALSO STATED THAT SHE IS STILL IN REHABILITATION AND IS WALKING WITH TWO CANES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DURASEAL PRODUCT DURASEAL SEALANT NQR CONFLUENT

    Patients

    Seq Age Sex Outcome Treatment
    1 Other