BEUDAMED
    FDA Adverse Event Other Summary report: N

    SEPRAGEL SINUS

    MDR report key: 692755 · Received March 6, 2006

    Report

    Report Number
    MW1038220
    Event Type
    Other
    Date Received
    March 6, 2006
    Date of Event
    December 3, 2005
    Report Date
    March 6, 2006
    Manufacturer
    GENZYME BIOSURGERY
    Product Code
    KHJ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT DEVELOPED TINGLING AND NUMBNESS OF THE RIGHT FACE FOUR DAYS AFTER USING SEPRAGEL SINUS DURING TYMPANOPLASTY. SEPRAGEL SINUS WAS USED TO FILL THE MIDDLE EAR TO HOLD THE GRAFT. HE LATER DEVELOPED TOTAL PARALYSIS OF THE RIGHT FACE 6 DAYS FOLLOWING TYMPANOPLASTY. HE HAD A MAGNETIC RESONANCE IMAGING -MRI- 1 WEEK AFTER THE RIGHT FACIAL PARALYSIS AND AN ENHANCING SOFT TISSUE FILLS THE RIGHT TYMPANIC CAVITY AND PORTIONS OF THE MASTOID WHICH I THINK REPRESENTS THE SEPRAGEL SINUS USED DURING THE PROCEDURE. THIS ABUTS AND OBSURES THE TYMPANIC AND MASTOID SEGMENTS OF THE FACIAL NERVE. HE WAS GIVEN DECADRON 10 MG I.V. FOLLOWED BY PREDNISONE FOR 3 WEEKS AND FAMVIR FOR 10 DAYS. HE RECOVERED UNEVENTFULLY 1 WEEK LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEPRAGEL SINUS HYALURONIC ACID - GEL FORM- KHJ GENZYME BIOSURGERY * 805031

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Other