BEUDAMED
    FDA Adverse Event Other Summary report: N

    GLUMA DESENSITIZER

    MDR report key: 2619861 · Received June 6, 2012

    Report

    Report Number
    9610902-2012-00021
    Event Type
    Other
    Date Received
    June 6, 2012
    Date of Event
    May 11, 2012
    Report Date
    May 11, 2012
    Manufacturer
    HERAEUS KULZER GMBH
    Product Code
    KLE
    PMA / PMN Number
    K962812
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) (THE IMPORTER) IS SUBMITTING THE REPORT ON BEHALF OF HERAEUS KULZER (B)(4) (THE MFR). TYPE OF REPORTABLE EVENT: THE DENTIST DID NOT SUFFER ANY INJURY DUE TO THE INCIDENT; WE'RE REPORTING TO BE COMPLAINT WITH 21 CFR PART 803. CONCLUSION: THE DIRECTIONS FOR USE STATES, "AVOID CONTACT WITH EYES AS THIS MAY CAUSE SERIOUS DAMAGE. WEAR SAFETY GLASSES AND ENSURE PT HAS ADEQUATE FACE PROTECTION."

    Description of Event or Problem · 1

    ON (B)(6) 2012, DR (B)(6) CALLED BECAUSE HE HAD GOTTEN GLUMA DESENSITIZER IN HIS RIGHT EYE. HE HAS FLUSHED THE EYE THOROUGHLY AND WANTED TO KNOW WHAT TO DO. HE HAD AN MSDS AND THAT IT SAID NOT TO GET IN YOUR EYES. (B)(4) RECOMMENDED THAT HE SEE AN EYE DOCTOR. HE SAID HE WAS GOING TO DO THIS AND THAT WE COULD CALL HIM BACK LATER. ON (B)(4) 2012, SPOKE TO DR (B)(6) HE SAID HE WAS BETWEEN PTS AND ONLY HAD A MOMENT. HE SAID HE SAW THE OPTOMETRIST, WHO DID NOT PRESCRIBE ANYTHING, BUT TESTED TO SEE IF THE GLUMA HAD GOTTEN ON TO THE CORNEA. HE SAID IT DID NOT. HE SAID THAT HE RINSED IT VERY QUICKLY AFTER THE SPLASH AND THAT THE EYE NEVER BURNED. HE SAID HE HAS A FOLLOW UP WITH THE OPTOMETRIST. I ASKED IF I COULD CALL BACK AFTER THE FOLLOW UP HE SAID THAT WOULD BE GOOD. HE SAID THAT I COULD CALL BACK ON (B)(4) 2012. ON (B)(4) 2012, SPOKE TO DR (B)(6). I ASKED HOW THE VISIT WITH THE OPTOMETRIST. HE SAID THAT IT WENT WELL AND THAT HIS EYE IS FINE. I ASKED IF WE COULD DO ANYTHING FOR HIM AND HE SAID THAT EVERYTHING WAS FINE AND HE REQUIRED NOTHING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention