BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLUMA DESENSITIZER

    MDR report key: 834567 · Received March 30, 2007

    Report

    Report Number
    1925223-2007-00001
    Event Type
    Injury
    Date Received
    March 30, 2007
    Date of Event
    February 28, 2007
    Report Date
    March 27, 2007
    Manufacturer
    HERAEUS KUZER GMBH
    Product Code
    KLE
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    DR. CALLED AND STATED: I GOT A DROP OF GLUMA DESENSITIZER (SINGLE DOSE) IN MY PATIENTS EYE. I RINSED THE EYE OUT. THE PATIENT STATES, THAT SHE HAS A FILM OVER HER EYE. WHAT SHOULD I DO? DR. CALLED BACK. THIS IS WHAT HAPPENED; SINGLE DOSE APPLICATOR REMOVED FROM OUTER PACKAGING AND PLACED ON PATIENT'S CHEST BY HIS ASSISTANT. DR GRABBED THE SINGLE DOSE APPLICATOR AND PUSHED IT IN INWARD, AND GLUMA SQUIRTED OUT AND HIT PATIENT'S EYE. SHE WAS NOT WEARING ANY GLASSES. THEY TOOK HER TO THE EYE STATION FOR THOROUGH IRRIGATION. SHE HAD SOME IRRITATION IN HER EYE, AND BLURRINESS, BUT IT CLEARED UP ON ITS OWN WITHIN APPROXIMATELY 8 HOURS. NO MEDICATION WAS TAKEN, NO DOCTOR VISIT. DR USING GLUMA FOR MANY YEARS AND SAID THIS WAS A FREAK ACCIDENT. HE STILL LOVES THE PRODUCT. AP FOLLOWUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLUMA DESENSITIZER RESIN TOOTH BONDING AGENT KLE HERAEUS KUZER GMBH SINGLE DOSE UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention