BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLUMA DESENSITIZER

    MDR report key: 3080675 · Received April 12, 2013

    Report

    Report Number
    1925223-2013-00053
    Event Type
    Injury
    Date Received
    April 12, 2013
    Date of Event
    March 19, 2013
    Report Date
    March 19, 2013
    Manufacturer
    HERAEUS KULZER GMBH
    Product Code
    KLE
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    PATIENT CALLED BECAUSE AT HIS DENTAL APPOINTMENT YESTERDAY GLUMA GOT INTO HIS EYE. HE SAID HE HAD SAFETY GLASSES ON BUT HE WAS LYING DOWN AND SOME MUST HAVE SPLASHED UNDER THE GLASSES WHILE SHE WAS APPLYING. HE SAID THAT THEY FLUSHED IT IMMEDIATELY AND FINISHED THE RESTORATION. HE SAID HE WAS SENT TO A (B)(6) DOCTOR AFTERWARD. HE SAID THAT THEY LOOKED AT IT AND FLUSHED IT MORE. HE SAID THAT THE DOCTOR SAID THAT IT WAS GOING TO BE FINE. HE SAID HE WENT BACK TODAY BECAUSE IT VERY IRRITATED AND SORE. THEY DID THE SAME THING. HE WANTED TO KNOW WHEN IT WOULD STOP HURTING. HE DID NOT HAVE MUCH TIME TO TALK AT THAT TIME. TOLD HIM THAT HEALING GENERALLY CAN TAKE UP TO 2 WEEKS, BUT THAT THE PHYSICIAN WOULD KNOW BEST. SPOKE TO THE DENTIST HE SAW YESTERDAY. SHE GAVE THE LOT NUMBER OF THE GLUMA SINGLE DOSE THAT THEY WERE CURRENTLY USING. SHE SAID THAT THEY THREW THE SINGLE DOSE AWAY AND THAT THEY NO LONGER HAD THAT VIAL. SHE SAID THAT THE EYE DOCTOR GAVE HIM NATURAL TEARS EYE DROPS AND A SALINE EYE WASH TO RINSE WITH. SHE SAID HIS EYE WAS VERY RED YESTERDAY, BUT LOOKS A LITTLE BETTER TODAY. SHE SAID SHE DOES NOT UNDERSTAND HOW THE GLUMA GOT IN HIS EYE WITH THE GLASSES ON. SHE SAID THAT SHE WAS APPLYING IT TO HIS TOOTH WHEN HE STOPPED HER AND SAT UP COMPLAINING THAT SOMETHING SPLASHED IN HIS EYE AND IT WAS HURTING. SHE SAID THAT THEY IMMEDIATELY RINSED THE EYE. SHE SAID SHE WILL CONTINUE TO MONITOR HIM UNTIL HE IS FULLY RECOVERED. ON (B)(6) 2013 SPOKE TO THE DENTIST. SHE SAID SHE SPOKE TO THE PATIENT LAST WEEK AND HE SAID THAT HE WAS BACK TO NORMAL. THAT HE HAD NO VISION ISSUES OR OTHER SYMPTOMS REMAINING. SHE SAID THAT SHE TOLD THE PATIENT TO CALL IF HE HAD ANYTHING NEW, BUT THAT SHE HAS HEARD NOTHING FROM HIM SINCE THAT CALL. PLEASE REFERENCE MFR REPORT# 9610902-2013-00053.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157800 GLUMA DESENSITIZER KLE TOOTH RESIN BONDING AGENT KLE HERAEUS KULZER GMBH 010202

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention