BEUDAMED
    FDA Adverse Event Other Summary report: N

    OPAL SEAL

    MDR report key: 2396653 · Received December 22, 2011

    Report

    Report Number
    1718912-2011-00008
    Event Type
    Other
    Date Received
    December 22, 2011
    Date of Event
    December 15, 2011
    Report Date
    December 21, 2011
    Manufacturer
    ULTRADENT PRODUCTS, INC.
    Product Code
    LBH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    OFFICE HAD AN OPAL SEAL SYRINGE TIP THAT WAS BLOCKED AND THE MATERIAL WAS EXPRESSED OUT OF THE SYRINGE INTO THE PATIENT'S EYE. THE PATIENT WAS A (B)(6) GIRL AND THEY IMMEDIATELY FLUSHED HER EYE WITH WATER. OFFICE WAS RELUCTANT TO PROVIDE A LOT OF THE INFORMATION NEEDED. ALL SHE WOULD SAY WAS THAT THE INCIDENT TOOK PLACE IN THEIR (B)(6) OFFICE IN (B)(6) AND THE TIP MAY HAVE BEEN ON THE SYRINGE FOR A WEEK. THE TIP WAS BLOCKED SO SHE APPLIED MORE PRESSURE AND THE TIP CAME OFF AND THE MATERIAL EXPRESSED OUT OF THE SYRINGE AND INTO THE PATIENT'S EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPAL SEAL SEALANT LBH ULTRADENT PRODUCTS, INC. 500061 B6HLN

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Hospitalization