BEUDAMED
    FDA Adverse Event Other Summary report: N

    ULTRACAL XS

    MDR report key: 2483294 · Received February 29, 2012

    Report

    Report Number
    1718912-2012-00002
    Event Type
    Other
    Date Received
    February 29, 2012
    Date of Event
    February 7, 2012
    Report Date
    February 27, 2012
    Manufacturer
    ULTRADENT PRODUCTS, INC.
    Product Code
    EJK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    SPOKE WITH (B)(6). SHE SAID THAT A PATIENT GOT CALCIUM HYDROXIDE IN THEIR EYE. THE EYE WAS PAINFUL AND STARTED TO SWELL. THEY HAD FLUSHED THE EYE THOROUGHLY WITH WATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRACAL XS CALCIUM HYDROXIDE CAVITY LINER EJK ULTRADENT PRODUCTS, INC. 5117 B0BRX

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization