BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWDER PORCELAIN

    MDR report key: 7191422 · Received January 15, 2018

    Report

    Report Number
    1718912-2017-00036
    Event Type
    Injury
    Date Received
    January 15, 2018
    Date of Event
    April 10, 2014
    Report Date
    December 19, 2017
    Manufacturer
    ULTRADENT PRODUCTS
    Product Code
    EIH
    PMA / PMN Number
    K951582
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    REFILING DUE TO ORIGINAL REPORT NOT BEING SUCESSFULLY UPLOADED TO DATA BASE

    Description of Event or Problem · 1

    DENTAL ASSISTANT PUSHED THE PLUNGER OF THE PORCELAIN ETCH AND IT APPERED TO BE CLOGGED. SHE THEN PUSHED HARDER. NO PORCELAIN ETCH CAME OUT THE SYRINGE. WHEN SHE WENT TO REMOVE THE TIP, THE PRESSURE SHE HAD CREATED LET OF COUPLE OF DROPS OF THE PRODUCT COME OUT OF THE SYRINGE AND LANDED IN HER EYE. SHE CLAIMS TO HAVE HAD SAFETY GLASSES ON. SHE IMMEDIATELY FLUSHED HER EYE WITH WATER AND SOUGHT MEDICAL ATTENTION AT THE LOCAL HOSPITAL. AT THE HOSPITAL , THEY PUT SALINE IN HER EYE FOLLOWED BY AN ANTIBOITIC. SHE WAS GIVEN SOME OINTMENT WHICH SHE BELIEVES TO BE MORE ANTIBIOTIC. HER VISION WAS SLIGHTLY BLURRED. SHE SAID THAT HER EYE WAS TEARING ALOT. SHE WENT TO THE HOSPITAL 5 DAYS LATER FOR A CHECK UP AND HER VISION WAS FINE. SHE STILL HAD SOME SORENESS WHEN SHE MOVES HER EYE. THE HOSPITAL TOLD HER THAT WAS NORMAL. THEY EXPECTED IT TO GO AWAY, WE SUGGESTED THAT SHE GET WRAP AROUND SAFETY GLASS AND NOT TO APPLY EXCESSIVE PRESSURE ON A PLUNGER IF A TIP APPEARS TO BE CLOGGED. A FOLLOW UP PHONE CALL CONFIRMED THAT SHE WAS FINE AND HAD NO FURTHER PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35222 POWDER PORCELAIN PORCELAIN ETCH EIH ULTRADENT PRODUCTS 406 B8VYL

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR