BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLUMA DESENSITIZER

    MDR report key: 1221784 · Received November 3, 2008

    Report

    Report Number
    1925223-2008-00001
    Event Type
    Injury
    Date Received
    November 3, 2008
    Date of Event
    October 7, 2008
    Report Date
    October 30, 2008
    Manufacturer
    HERAEUS KULZER, GMBH
    Product Code
    KLE
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    MA, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    FEMALE PATIENT WAS AT THE DENTIST FOR AN EMERGENCY TREATMENT ON #13 MOD. THE ASSISTANT WAS HANDLING THE GLUMA DISPENSER WITH GLUMA IN THE WELL AND SPONGE TIPPED OUT OF THE ASSISTANT'S HAND. WHEN THIS HAPPENED, THE GLUMA FLEW INTO THE AIR AND A DROP LANDED IN THE PATIENT'S LEFT EYE. THE PATIENT WAS NOT WEARING EYE PROTECTION AND SHE WAS IN A RECLINED POSITION. THEY SET HER UP IMMEDIATELY, RINSED HER LEFT EYE OUT WITH WATER, CALLED THE ER, FAXED THE ER A COPY OF THE MSDS SHEET AND SENT THE PATIENT TO THE ER AFTER PLACING A GAUZE SQUARE OVER HER EYE TO KEEP IT CLOSED. THE DENTIST DID NOT GIVE ANY PHARMACEUTICALS TO THE PATIENT. THE PATIENT RETURNED TO HAVE TREATMENT COMPLETED ON (B) (6) 2008. THE PATIENTS LEFT EYE WAS SWOLLEN AND RED AT THE ER. THE ER REFERRED THE PATIENT TO AN OPHTHALMOLOGIST WHO STATED IN THE REPORT TO THE DENTIST THAT THE GLUMA HAD MELTED AWAY THE SCLERA ON THE LEFT EYE. THE OPHTHALMOLOGIST PRESCRIBED ERYTHROMYCIN OINTMENT TO BE APPLIED 4 TIMES PER DAY. HE ALSO WANTS HER TO RETURN IN 2 WEEKS IF SYMPTOMS PERSIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLUMA DESENSITIZER TOOTH RESIN BONDING AGENT KLE HERAEUS KULZER, GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention