BEUDAMED
    FDA Adverse Event Other Summary report: N

    GLUMA DESENSITIZER

    MDR report key: 1879035 · Received October 15, 2010

    Report

    Report Number
    9610902-2010-00003
    Event Type
    Other
    Date Received
    October 15, 2010
    Date of Event
    September 1, 2010
    Report Date
    October 3, 2010
    Manufacturer
    HERAEUS KULZER GMBH
    Product Code
    KLE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE DID NOT CAUSE A SERIOUS INJURY, HOWEVER, THE EVENT COULD HAVE CONTRIBUTED TO A SERIOUS INJURY. THIS DEVICE DID NOT CAUSE A SERIOUS INJURY, HOWEVER, COULD HAVE CONTRIBUTED TO A SERIOUS INJURY. THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE LABELING SPECIFICATION INDICATES THE REQUIREMENT FOR EYE PROTECTION FOR THE USER AND PT. THE INJURY EXPERIENCED IS A RESULT OF THE DENTIST DROPPING THE PRODUCT IN THE PT'S EYE. NECESSARY PRECAUTIONS TO PROTECT THE EYE WAS NOT PROTECTED BY THE DENTIST.

    Description of Event or Problem · 1

    DENTIST CALLED AND SAID THAT SHE HAD A PT THAT SHE WAS TREATING AND GLUMA DESENSITIZER BEFORE PLACING A FILLING. SHE SAID SHE HAD GLASSES ON HIM, BUT SHE COULDN'T SET HIM BACK ALL THE WAY. SHE SAID THAT WHEN SHE AIR-DRIED IT SPRAYED INTO THE PT'S EYE. SHE ASKED IF IT WAS ACIDIC OR BASIC. I SENT HER THE MSDS AS IT LISTS THE PH AT 4.0. I ASKED HER IF SHE HAD TIME TO ANSWER A FEW QUESTIONS AS WE LIKE TO DOCUMENT AND TRACK THE PT'S CONDITION. SHE SAID SHE HAD TIME. I ASKED HER WHICH TOOTH SHE WAS WORKING ON AND WHAT PROCEDURE SHE WAS DOING. SHE SAID SHE WAS PLACING A LINGUAL ON # 7. SHE SAID SHE COULD ONLY SEAT THE PT BACK AT 45 DEGREES AND SHE WAS BASICALLY WORKING UPSIDE DOWN. SHE SAID THAT PREPARED THE TOOTH AS USUAL AND APPLIED A SMALL AMOUNT OF GLUMA DESENSITIZER. SHE SAID WHEN IT SPRAYED THE PT DID NOT NOTICE ANY BURNING FOR 5 TO SECONDS. SHE SAID SHE SAT HIM UP AND RINSED HIS EYES IN A WATER BATH FOR 15 MINS. SHE SAID HE DID NOT HAVE ANY OTHER PRODUCT USED AT THIS TIME AND THAT THEY CALLED THE PT'S OPHTHALMOLOGIST AND HE IS SEEING HER AT 4 PM TODAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLUMA DESENSITIZER TOOTH RESIN BONDING AGENT KLE HERAEUS KULZER GMBH 66001854 010095

    Patients

    Seq Age Sex Outcome Treatment
    1 Other