BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNAERO HEMOSTATIC GEL

    MDR report key: 2017241 · Received March 9, 2011

    Report

    Report Number
    3008045885-2011-00001
    Event Type
    Injury
    Date Received
    March 9, 2011
    Date of Event
    December 17, 2010
    Report Date
    March 8, 2011
    Manufacturer
    HEMCON MEDICAL TECHNOLOGIES EUROPE, LTD.
    Product Code
    LMF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN CONDUCTED AN ENDOSCOPIC SINUS SURGERY ON WEDNESDAY, (B)(6) AND THE PT WENT HOME AFTER 1-2 HOURS. AFTER ONE SIDE OF THE NOSE CONTINUED TO BLEED THE PT WENT BACK TO (B)(6) HOSPITAL, WHERE A RAPID RHINO (ARTHROCARE ENT NASAL CATHETER POSTERIOR EPISTAXIS DEVICE) 4.5 CM PACK WAS INSERTED. LATER A 7 CM RAPID RHINO PACK HAD TO BE UTILIZED TO PROVIDE ADDITIONAL PRESSURE. THE PT WAS KEPT OVERNIGHT (WEDNESDAY) AND RELEASED ON THURSDAY. ON (B)(6), THE PT CONTINUED TO HAVE OOZING BLEEDING, SO PHYSICIAN BROUGHT THE PT BACK IN FOR SURGERY, LOCATED THE SOURCE OF BLEEDING FROM THE ETHMOID SITE AND CAUTERIZED. FURTHERMORE, PHYSICIAN APPLIED FLOSEAL (BAXTER HEMOSTATIC MATRIX) AND RIBBON GAUZE. PHYSICIAN HAD ADD'L BLOOD ANALYSIS DONE ON THE PT TO CONFIRM THERE WERE NO BLOOD DISORDERS, AND THE HEMATOLOGIST REPORTED EVERYTHING WAS NORMAL. THE FOLLOWING (B)(6), DURING THE PT'S F/U, ALL PACKING WAS REMOVED AND PT WAS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNAERO HEMOSTATIC GEL INTRANASAL SEPTAL SPLINT LMF HEMCON MEDICAL TECHNOLOGIES EUROPE, LTD. H26 006

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention