BEUDAMED
    FDA Adverse Event Other Summary report: N

    GLUMA DESENSITIZER

    MDR report key: 2163444 · Received June 2, 2011

    Report

    Report Number
    9610902-2011-00006
    Event Type
    Other
    Date Received
    June 2, 2011
    Date of Event
    May 26, 2009
    Report Date
    May 26, 2011
    Manufacturer
    HERAEUS KULZER, GMBH
    Product Code
    KLE
    PMA / PMN Number
    K962812
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING SUBMITTED AS A RESULT OF CORRECTIVE ACTION MEASURES TO FDA FINDINGS.

    Description of Event or Problem · 1

    ACCORDING TO THE INCIDENT REPORT OF (B)(6), THE PT DID FEEL A PRICKLE IN THE MUCOSA OF THE CHEEK IMMEDIATELY AFTER APPLICATION OF GLUMA DESENSITIZER (GD). WITHIN TWO DAYS THE PT DID DEVELOP A SEVERE SWELLING OF THE CHEEK AND LATER ALSO OF THE TONGUE AND LOWER LIP. THE PT WAS INITIALLY TREATED WITH ANTIHISTAMINE WITHOUT ANY EFFECT AND SUBSEQUENTLY WITH STEROIDS WHICH DID HAVE EFFECT - THE SWELLING DISAPPEARED WITHIN SOME HOURS. THE PT DID NOT USE ANY MEDICATION AND DID NOT HAVE ANY COMMON DISEASES. FURTHER INFO WAS GIVEN BY THE DENTIST VIA MAILS ON (B)(6) 2009: THE DENTIST APPLIED GD ON (B)(6) 2009 ON SENSITIVE ROOT SURFACES OF A FEMALE PT. THE RIGHT UPPER MOLARS AND THE PREMOLARS IN THE LEFT LOWER JAW WERE TREATED. ALL TEETH HAD BEEN CLEANED PREVIOUSLY WITH ULTRASONIC CURETTAGE AND POLISHED WITH ROTATING INSTRUMENTS USING PIMPSTONE PLUS TOOTHPASTE AND GLYCERIN - PASTE. THE DENTIST USED A BLUE-STICK AFTER DRYING THE SURFACE. THE GD WAS APPLIED FOR ABOUT 10 SECONDS, AIR-DRIED, ONLY RINSED OFF BY THE PT HERSELF. THE TEETH WERE NOT ISOLATED AS SUCH BUT A COTTON TAMPON WAS USED TO KEEP THE TOOTH DRY, AND TO PREVENT CONTACT WITH ENDOTHELIAL TISSUE. ON (B)(6), THE PT WOKE UP LOOKING VERY SWOLLEN IN THE RIGHT SIDE ON THE FACE. THE PT CALLED HER CLINIC AND WAS TOLD TO TAKE SOME ANTIHISTAMINE. THE PT IS A NURSE HERSELF AND HAS EASY ACCESS TO MEDICINE DUE TO DRS AROUND HER. BUT THE ANTIHISTAMINE DID NOT HELP AT ALL. THE DENTIST CALLED THE PT ON (B)(6). THE LOWER LIP AND TONGUE OF THE PT WERE SWOLLEN NOW AND THE PT HAD DIFFICULTIES WITH SWALLOWING TOO. THE DENTIST RECOMMENDED SEEING A DR OR AN ER AS SOON AS POSSIBLE. THE PT WENT TO A DR WHO SUBSCRIBED CORTICO-STEROIDS ("BINYREBARKHORMONE"). AFTER HAVING HAD THE CORTICO-STEROID, THE PT IS ALRIGHT AGAIN AND THE SWALLOWING DISAPPEARED WITHIN SOME HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLUMA DESENSITIZER KLE TOOTH RESIN BONDING AGENT KLE HERAEUS KULZER, GMBH 020089

    Patients

    Seq Age Sex Outcome Treatment
    1 Other