BEUDAMED
    FDA Adverse Event Death Summary report: N

    VENUS COMPOSITE

    MDR report key: 2841279 · Received November 7, 2012

    Report

    Report Number
    9610902-2012-00158
    Event Type
    Death
    Date Received
    November 7, 2012
    Date of Event
    May 7, 2010
    Report Date
    October 8, 2012
    Manufacturer
    HERAEUS KULZER GMBH
    Product Code
    EBF
    PMA / PMN Number
    K020131
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) (THE IMPORTER) IS SUBMITTING THE REPORT ON BEHALF OF HERAEUS KULZER (B)(4) (THE MANUFACTURER). THE DENTIST STATED HE HAS NEVER USED GLUMA DESENSITIZER OR VENUS FLOW. HE WAS NOT CERTAIN IF HE USED VENUS COMPOSITE OR Z250 COMPOSITE FOR THIS PT IT IS FOR THAT REASON THE REPORT IS BEING SENT. ALTHOUGH WE HAVE NOT ESTABLISHED THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE EVENT, WE'RE REPORTING IT OUT OF CAUTION TO BE COMPLAINT WITH 21 CFR PART 803. WE CANNOT RULE OUT CAUSALITY. NARRATIVE FOR CONCLUSION - THE PT WAS ADVISED TO HAVE ALLERGY TESTING TO DETERMINE IF THE PT HAD ALLERGIC REACTION TO ONE OF THE MATERIALS USED. ALLERGIES TO DENTAL MATERIALS ARE RARE, BUT DOCUMENTED. THE DIRECTIONS FOR USE FOR VENUS STATES "DO NOT USE VENUS IN PTS, WHICH ARE ALLERGIC AGAINST THE INGREDIENTS OF VENUS." THE PT HAS NOT REPORTED SEEING AN ALLERGIST SO CAUSE OF THE SYMPTOMS IS UNKNOWN AT THIS TIME.

    Description of Event or Problem · 1

    TWO REPORTS FILED FOR THE ALLEGED INCIDENCES AS THE DENTIST PLACED RESTORATIONS WERE PLACED ON TWO SEPARATE EVENT DATES. SEE ALSO MFR. REPORT # 9610902-2012-00157. ON (B)(4) 2012, SPOKE TO THE PT HE STATED THAT HE HAD 5 FILLINGS PLACED AT THE GUM LINE ABOUT TWO AND HALF YEARS AGO. HE SAID THAT GLUMA DESENSITIZER, BRUSH AND BOND BY (B)(6), AND VENUS FLOW WERE USED. HE SAID THAT HE HAS NOT FELT WELL SINCE AND HAS LOST HIS JOB AND ABILITY TO WORK DUE TO HOW SICK HE IS. HE SAID THAT HE IS DYING AND HIS ONLY RELIEF IS SLEEPING. HE SAID THAT HE IS A SHUT IN NOW AND THAT HE FEELS LIKE KILLING HIMSELF TO END THE PAIN. HE ASKED WHAT CAN BE DONE. I ASKED IF HE HAS HAD THE FILLING REMOVED. HE SAID THAT NO ONE HAD SUGGESTED THAT TILL RECENTLY WHEN HE SPOKE TO A DENTIST AT (B)(6). I ASKED IF HE HAS BEEN HIS PHYSICIAN OR AN ALLERGIST. HE SAID THAT HIS PHYSICIAN HAD MOVED RECENTLY AND THAT HE HAS AN APPOINTMENT WITH A NEW PHYSICIAN ON (B)(6) 2012. HE SAID HE WENT TO THE ONLY ALLERGIST TOOK (B)(6), BUT THAT SHE DID NOT TEST HIM FOR ANYTHING AND THAT TOLD HIM IT WAS IN HIS HEAD. I ASKED IF HE HAS RETURNED TO THE DENTIST AND HE SAID THAT THE LAST TIME HE SAW HIM, THE DENTIST CALLED THE POLICE ON HIM. HE SAID THE DENTIST DID NOT WANT TO SEE HIM ANYMORE AFTER THE MEMOS HE SENT TO THE DENTIST ABOUT HOW BAD HE WAS FEELING, ACID COMING FROM HIS TEETH, AND WANTING TO KILL HIMSELF. HE SAID HE TRIED TO SEE OTHER DENTISTS, BUT HE GETS DISMISSED AS A PT. HE SAID THAT THE (B)(6) SCHOOL THREW HIM OUT. I TOLD HIM I WOULD CALL THE DENTIST TO GET TREATMENT INFORMATION. HE SAID THAT THE DENTIST HAS BEEN VERY UNCOOPERATIVE. HE SAID THAT THE DENTIST USED NOVOCAINE AND DRILLED HIS TEETH. HE SAID THAT HE STARTED FEELING ILL IMMEDIATELY. HE SAID WHEN THE DENTIST PLACED THE FIRST PRODUCT ON HIS TEETH HE NOTICED A SICK FEELING. HE SAID AT FIRST HE THOUGHT IT WAS THE NOVOCAINE SO HE WENT BACK FOR THE SECOND APPOINTMENT. HE SAID HE JUST GOT SICKER INSTEAD OF BETTER. HE SAID HE IS DESPERATE AND NEEDS US TO HELP HIM. I TOLD WE WOULD BE ABLE TO PROVIDE ASSISTANCE TO THE ALLERGIST IN DIAGNOSIS OF A POTENTIAL ALLERGY. HE SAID THAT IS WHAT THE DENTIST AT (B)(6) SAID. ON (B)(4) 2012, SPOKE TO THE DENTIST. HE REPORTED USING SUPERSEAL, BRUSH AND BOND AND DID NOT WRITE THE COMPOSITE IN THE CHART. HE SAID HE USED THE FIRST 2 PRODUCTS ALONG TIME SO HE IS SURE OF THEM. HE SAID HE HAS USED VENUS COMPOSITE AND Z250 IN THE TIME THE PT WAS SEEN. HE SAID THAT HE HAS NEVER USED GLUMA DESENSITIZER OR VENUS FLOW. HE SAID THAT HE DID NOTE THAT HE USED SHADE A2. HE GAVE THE TREATMENT DATES AND SAID THAT HE DISMISSED THE PT FROM THE PRACTICE BECAUSE OF HIS BEHAVIOR AND ACCUSATIONS. ATTEMPTS HAVE BEEN MADE TO REACH THE PT. THE CALLS DID NOT GO TO VOICE MAIL. WILL WAIT TILL PT CALLS BACK AS UNABLE TO REACH PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENUS COMPOSITE EBF MATERIAL, TOOTH SHADE, RESIN EBF HERAEUS KULZER GMBH A2

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other