BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLUMA DESENSITIZER

    MDR report key: 5919766 · Received August 31, 2016

    Report

    Report Number
    9610902-2016-00016
    Event Type
    Injury
    Date Received
    August 31, 2016
    Date of Event
    August 2, 2016
    Report Date
    August 30, 2016
    Manufacturer
    HERAEUS KULZER GMBH
    Product Code
    LBH
    PMA / PMN Number
    K962812
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AS ALLOWED BY EXEMPTION #E2012008, HERAEUS KULZER, LLC (THE IMPORTER) IS SUBMITTINGTHE REPORT ON BEHALF OF HERAEUS KULZER GMGH (THE MANUFACTURER). ALTHOUGH WE HAVE NOT ESTABLISHED THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE EVENT, WE'RE REPORTING IT TO BE COMPLIANT WITH 21 CFR PART 803 AND OUT OF AN ABUNDANCE OF CAUTION. HERAUES KULZER, LLC HAS MADE SEVERAL ATTEMPT TO COLLECT ADDITIONAL INFORMATION. ON 8/4/2016- CALLED AND LEFT A MESSAGE STATING WE NEEDED TO SPEAK WITH (B)(6). (ORIGINAL CALLER) IN REGARDS TO THIS ALLEGATION. ASKED FOR A RETURN CALL. ON 8/19/2016-SPOKE WITH (B)(6). SHE EXPLAINED THIS WAS NOT A PATIENT THAT THEY TREATED BUT THAT OF ANOTHER PROVIDER. A DDS HAD CONTACT THEM IN HOPES TO OBTAIN MEDICAL ADVICE FOR TREATING THE PATIENT. THE MEDICAL CENTER WAS NOT CERTAIN AS TO WHAT/IF ANY TREATMENT WAS RECOMMENDED OR ADMINISTERED TO THE PATIENT. SHE WAS NOT ABLE TO PROVIDE ME WITH ANY ADDITIONAL INFORMATION INCLUDING THE EXACT NAME OF THE PRODUCT. SHE WOULD NOT RELEASE ANY OF THE TREATING DDS INFORMATION SO THEY HERAEUS KULZER COULD CONTACT THEM DIRECTLY. MY CONTACT INFORMATION WAS GIVEN AND REQUESTED THAT SHE PLEASE GIVE IT TO THE PROVIDER FOR THEM TO CONTACT ME AS ADDITIONAL INFORMATION WAS NEEDED. ON 8/25/2016- CONTACTED THE MEDICAL CENTER TO FOLLOW UP ON WHETHER OR NOT THE CONTACT INFORMATION HAD BEEN GIVEN TO THE TREATING DDS. I WAS INFORMED IT HAD BEEN. THE MEDICAL CENTER AT THIS TIME HAD NO ADDITIONAL INFORMATION. DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    A MEDICAL CENTER CONTACTED US AFTER A TREATING DDS CALLED SEEKING MEDICAL ADVICE FOR A PATIENT WHO DEVELOPED A SWOLLEN LIP AFTER THE USE OF GLUMA. THE MEDICAL CENTER WAS CALLING ON BEHALF OF THE DDS AND WAS NOT ABLE TO PROVIDE ANY ADDITIONAL INFORMATION INCLUDING THE EXACT NAME OF THE PRODUCT USED, APPLICATION, DURATION OF APPLICATION, ISOLATION TECHNIQUE AND SO ON. THE CONTACTING MEDICAL CENTER WOULD NOT RELEASE THE TREATING DDS'S INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570403 GLUMA DESENSITIZER ENAMEL DESENSITIZER LBH HERAEUS KULZER GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Other