BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOREZ

    MDR report key: 480879 · Received August 29, 2003

    Report

    Report Number
    1718912-2003-00002
    Event Type
    Injury
    Date Received
    August 29, 2003
    Date of Event
    April 21, 2003
    Report Date
    May 5, 2003
    Manufacturer
    ULTRADENT PRODUCTS, INC.
    Product Code
    KLE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT DEVELOPED SYMPTOMS OF WHEEZING, COUGHING, SHORTNESS OF BREATH IMMEDIATELY FOLLOWING OBTURATION WITH THE ENDOREZ PRODUCT. PATIENT WAS RUSHED TO HOSPITAL AND DIAGNOSED AS AN ALLERGIC REACTION. PATIENT WAS TREATED AND RELEASED. PATIENT HAS HAD A FULL RECOVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOREZ ENDODONTIC FILLING AND SEALING MATERIAL. KLE ULTRADENT PRODUCTS, INC. NA 53H0 BATCH EZABC & ERAAB

    Patients

    Seq Age Sex Outcome Treatment
    1 * Hospitalization| O