BEUDAMED
    FDA Adverse Event Summary report: N

    RETREAT CLEAR HEMOSTATIC GEL

    MDR report key: 2396767 · Received December 22, 2011

    Report

    Report Number
    1718912-2011-00009
    Date Received
    December 22, 2011
    Date of Event
    November 9, 2011
    Report Date
    December 22, 2011
    Manufacturer
    ULTRADENT PRODUCTS, INC.
    Product Code
    LBH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    DOCTOR FROM OFFICE USED PRODUCT ON GIRL AND SHE HAD A REACTION, POSSIBLE, IT COULD ALSO BE ANOTHER PRODUCT - TOPICAL HEMOSTATIC SOLUTION. SHE WAS TREATED ON (B)(6) 2011 AT PROVIDENT PACIFIC CAMPUS ON (B)(6) 2011. SHE WAS THERE FOR 4 DAYS AND HAD TO BE INTUBATED DURING THIS TIME. THE DOCTOR DOES NOT HAVE PRODUCT TO RETURN BECAUSE THE REST OF PRODUCT HAS BEEN USED. THE DOCTOR WILL BE OUT OF THE COUNTRY FOR 4 WEEKS STARTING (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RETREAT CLEAR HEMOSTATIC GEL HEMOSTATIC GEL LBH ULTRADENT PRODUCTS, INC. 8947 B6564R

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Hospitalization HEMOSTATIC GEL