BEUDAMED
    FDA Adverse Event Summary report: N

    VENUS TEMP 2

    MDR report key: 4071178 · Received September 9, 2014

    Report

    Report Number
    3005665377-2014-00007
    Date Received
    September 9, 2014
    Date of Event
    July 29, 2014
    Report Date
    August 12, 2014
    Manufacturer
    HERAEUS KULZER GMBH
    Product Code
    EBG
    PMA / PMN Number
    K960938
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. METHOD, RESULTS, CONCLUSION: BECAUSE THE MALFUNCTION ALLEGATION COULD NOT BE CONFIRMED, THE CAUSE OF THE ADVERSE REACTION COULD NOT BE DETERMINED. THIS IS CLASSIFIED AS A NEAR INCIDENT IN THAT THE TIMELY INTERVENTION OF MEDICAL STAFF WILL PREVENT ANY LASTING DAMAGE OR IMPAIRMENT TO THE PATIENT'S PHYSICAL STATE. EVALUATION SUMMARY: BECAUSE SAID PRODUCT HAS NOT BEEN RETURNED, THERE IS NO COMPELLING PROOF OF CAUSATION OF ANY ADVERSE EFFECTS. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    DDS REPORTED TO HK (B)(4) - ADVERSE REACTION TO VENUS PROVISIONAL MATERIAL. FEMALE PATIENT HAD TEMPS PLACED TWO WEEKS AGO, REPORTEDLY HAD SWELLING LIPS WHICH DDS CHARACTERIZED AS ANGIONEUROTIC EDEMA OF THE LIP. (B)(4) CALLED TO GET MORE INFORMATION AND SPOKE WITH DDS. THE PATIENT WORKS IN A MEDICAL OFFICE AND MEDICATED WITH BENADRYL AND RX PREDNISONE. SHE DID NOT INFORM DDS OF HER ADVERSE REACTION UNTIL YESTERDAY ((B)(6) 2014). PATIENT STILL HAS A SWOLLEN LIP. DDS STATED PATIENT HAD NO KNOWN ALLERGIES, THAT HE HAD USED VENUS TEMP II. ASKED PERMISSION FOR DOUG TO MAKE A FOLLOW-UP CALL TO ENSURE THIS WAS HANDLED COMPLETELY AND PROPERLY. DDS CALLED IN RESPONSE TO OLDER INQUIRY FOR HIS PHONE NUMBER, WAS TRANSFERRED OVER TO (B)(4). DDS STATED THAT THE PATIENT IS IN HER (B)(6). THE PREPS WERE 6-11 AND THE UPPER LIP IS THE ONLY LIP AFFECTED. HE SAID THAT SHE CALLED HIM THE DAY AFTER AND HE DIDN'T REPORT IT BECAUSE HE DIDN'T THINK IT WOULD LAST MORE THAN A DAY OR 2. HE HAS NOT DONE ANY OTHER CROWNS ON THIS PATIENT, SO HE HAS NOT EXPERIENCED THIS WITH HER BEFORE. HE SAID HE HAD TO GO BEFORE I COULD GET A SHADE AND LOT NUMBER. I DID ASK IF WE COULD FOLLOW UP IN A WEEK TO SEE HOW THE PATIENT IS PROGRESSING. HE SAID WE COULD. THIS INCIDENT IS REPORTABLE ACCORDING TO 21 CFR 803. THE FDA DEFINES THIS AS A SERIOUS INJURY (21 CFR SEC. 803.3) AS THE PATIENT REPORTED HAVING AN ADVERSE REACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    553313 VENUS TEMP 2 CROWN AND BRIDGE, TEMPORARY RESIN EBG HERAEUS KULZER GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention