BEUDAMED
    FDA Adverse Event Other Summary report: N

    GLUMA DESENSITIZER

    MDR report key: 2265651 · Received September 23, 2011

    Report

    Report Number
    9610902-2011-00016
    Event Type
    Other
    Date Received
    September 23, 2011
    Date of Event
    July 8, 2011
    Report Date
    September 22, 2011
    Manufacturer
    HERAEUS KULZER GMBH
    Product Code
    KLE
    PMA / PMN Number
    K962812
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    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 PATIENT. THE INJURY EXPERIENCED IS A RESULT OF THE DENTIST DROPPING THE PRODUCT IN THE PATIENT'S EYE. NECESSARY PRECAUTION TO PROTECT THE EYE WAS NOT PROTECTED BY THE DENTIST.

    Description of Event or Problem · 1

    DR. (B)(6), CALLED WITH A PATIENT THAT WAS JUST IN FOR A ROUTINE FILLING. THE PATIENT IS A (B)(6) MALE. THE DOCTOR SAID AS HIS ASSISTANT HANDED THE MICRO BRUSH WITH THE GLUMA DESENSITIZER ON IT TO HIM; A SMALL DROP FELL IN THE PATIENT'S EYE. THE PATIENT WAS NOT WEARING GLASSES. THE DOCTOR ASKED WHAT HE SHOULD DO AND I EXPLAINED THE MSDS SAYS THE EYE NEEDS TO BE FLUSHED WITH RUNNING WATER AND THE PATIENT SHOULD SEE HIS DOCTOR. HE SAID THEY FLUSHED HIS EYES FOR SEVERAL MINUTES AND RELEASED HIM BECAUSE HE WAS FEELING MUCH MORE COMFORTABLE. THE DOCTOR SAID HE TOLD THE PATIENT TO SEE HIS DOCTOR IF HE HAS PAIN WITH THE EYE. DR. (B)(6) SAID THE EYE WAS STILL RED WHEN THE PATIENT LEFT BUT WAS NOT IN PAIN. THE DOCTOR WAS ASKED IF WE COULD SEND HIM THE MSDS AND DFU AND HE SAID THAT HE DID NOT NEED THEM. THE DOCTOR WAS ASKED IF WE COULD CONTACT HIM NEXT WEEK TO FOLLOW UP ON THIS AND HE SAID WE COULD. ON (B)(6) 2011, WE CALLED AND SPOKE WITH (B)(6). SHE SAID THE PATIENT IS FINE AND THERE HAVE BEEN NO FURTHER INCIDENTS. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLUMA DESENSITIZER KLE TOOTH RESIN BONDING AGENT KLE HERAEUS KULZER GMBH 010096

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Other