BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLUMA DESENSITIZER

    MDR report key: 2163452 · Received June 21, 2011

    Report

    Report Number
    9610902-2011-00004
    Event Type
    Injury
    Date Received
    June 21, 2011
    Date of Event
    April 15, 2011
    Report Date
    May 19, 2011
    Manufacturer
    HERAEUS KULZER GMBH
    Product Code
    KLE
    PMA / PMN Number
    K962812
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT WAS NOT RETURNED, NOR WAS THERE ANY PRODUCT SPECIFICS SUCH AS LOT NUMBER PROVIDED FOR AN EVALUATION TO BE PERFORMED.

    Description of Event or Problem · 1

    PATIENT SAID SHE WENT TO HER DENTIST OFFICE FOR A ROUTINE CLEANING AND HAD SOME GUM EROSION. SHE SAID THE DENTIST APPLIED A GLUMA DESENSITIZER TO 4 TEETH, ALL LOWER, ONE BACK TOOTH PER SIDE AND ONE FRONT TOOTH PER SIDE. SHE SAID THAT AT THE TIME, SHE COULDN'T BELIEVE HOW WONDERFUL THIS PRODUCT WAS, SHE HAD NO SENSITIVITY AT ALL. SHE SAID AT 24 HOURS AFTER TREATMENT, HER LIPS STARTED TINGLING. AT 30 HOURS, HER THROAT WAS CLOSED, HER TONGUE WAS SWOLLEN TO 5X ITS NORMAL SIZE, AND HER LIPS WERE SWOLLEN TO 3X THEIR NORMAL SIZE. SHE WENT TO THE HOSPITAL AND THEY GAVE HER PREDNISONE, WHICH SEEMS TO BE WORKING. SHE SAID THIS WAS SATURDAY AND IT IS NOW TUESDAY AND SHE IS FINALLY BEGINNING TO SEE RELIEF FROM THE SWELLING. THE PATIENT WAS ASKED IF ANYTHING ELSE WAS USED DURING THE CLEANING AND SHE SAID NO. WHEN ASKED HOW THE PRODUCT WAS APPLIED, THE PATIENT SAID IT WAS APPLIED WITH A BENT COTTON TIPPED APPLICATOR. THE PATIENT WAS ASKED IF THE DOCTOR RINSED HER MOUTH WITH WATER AFTERWARDS AND SHE SAID SHE THINKS HE DID NOT RINSE, BUT IS NOT SURE. THE PATIENT WAS ASKED IF SHE HAD CONTACTED THE DENTAL OFFICE REGARDING THIS AND SHE SAID SHE HAS BEEN IN CONTACT WITH THEM QUITE FREQUENTLY. THE PATIENT WAS ASKED ABOUT CONTACTING THE DENTIST AND SHE REPORTED THAT THE DENTIST WAS ON HOLIDAY FOR 2 WEEKS. PATIENT SAID SHE ASKED HER DOCTOR FOR THE PRODUCT TO GIVE HER PHARMACIST TO SEE WHAT INGREDIENT TO WHICH SHE MAY HAVE BEEN ALLERGIC. THE DOCTOR TOLD HER THIS WAS THE LAST BOTTLE THEY HAD AND THEY HAD THROWN THE BOX AWAY A LONG TIME AGO AND HAD JUST RECENTLY THROWN THE BOTTLE AWAY. THEY TOLD HER THEY HAVE NOTHING TO GIVE HER. THE PATIENT HAS KNOWN ALLERGIES INCLUDE MOLD AND PENICILLIN AND AMOXICILLIN. SHE TAKES NO OTHER MEDICATIONS CURRENTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLUMA DESENSITIZER TOOTH RESIN BONDING AGENT KLE HERAEUS KULZER GMBH 65872354 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other