BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENUS DIAMOND PLT REFILL 1X10X0,25G BXL

    MDR report key: 13695391 · Received March 8, 2022

    Report

    Report Number
    1821514-2022-00001
    Event Type
    Injury
    Date Received
    March 8, 2022
    Date of Event
    February 9, 2022
    Report Date
    March 7, 2022
    Manufacturer
    KULZER, GMBH-HQ
    Product Code
    EBF
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    UK
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS INCIDENT IS REPORTABLE ACCORDING TO 21 CFR 803. THE FDA DEFINES THIS AS A SERIOUS INJURY (21 CFR SEC. 803.3) AS THE OFFICE STAFF REPORTED THE PATIENT HAVING AN ALLERGIC TYPE REACTION. THE INCIDENT WILL BE REPORTED TO MAINTAIN COMPLIANCE WITH 21 CFR 803 AND OUT OF AN ABUNDANCE OF CAUTION. PATIENT SUFFERED A RASH IMMEDIATELY AFTER THE VENUS DIAMOND COMPOSITE WAS PLACED, THE PATIENT DID NOT RECEIVE ANESTHETIC FOR THIS PROCEDURE. THE COMPOSITE WAS REMOVED THE SAME DAY AND THE RASH SUBSIDED WITHIN 24 HOURS. THE PATIENT EXPERIENCED LUMPS ON HER LIPS, BLISTERS AND CRUST ON THE SIDE OF HER MOUTH THAT SUBSIDED IN 3 DAYS. THE PATIENT WAS PRESCRIBED AN ANTIHISTAMINE AND AN APPOINTMENT WITH HER GENERAL PRACTITIONER. AN ALLERGY TEST HAS NOT BEEN COMPLETED AT THIS TIME AND IT IS UNKNOWN IF AN ALLERGY TEST WILL BE CONDUCTED. WE CANNOT DETERMINE IF OUR PRODUCT DID OR DID NOT CAUSE THIS ALLERGIC TYPE REACTION, THEREFORE WE WILL REPORT THIS INCIDENT OUT OF AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 0

    THIS EVENT TOOK PLACE IN (B)(6). PATIENT SUFFERED RASH AFTER COMPOSITE FILLING WAS PLACED. NO ANESTHETIC WAS USED FOR THIS PROCEDURE. COMPOSITE WAS REMOVED SAME DAY AND THE RASH WAS GONE WITHIN 24 HOURS. THE PATIENT EXPERIENCED LUMPS ON HER LIPS, BLISTERS AND CRUST ON THE SIDES OF HER MOUTH FOR 3 DAYS AFTERWARDS. THE PATIENT WAS PRESCRIBED AN ANTIHISTAMINE AND AN APPOINTMENT WITH HER GENERAL PRACTITIONER. AN ALLERGY TEST HAS NOT BEEN COMPLETED AT THIS TIME AND IT IS UNKNOWN IF AN ALLERGY TEST WILL BE CONDUCTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674095 VENUS DIAMOND PLT REFILL 1X10X0,25G BXL DENTAL COMPOSITE, RESIN DEVICES, PRODUCT CODE: EBF EBF KULZER, GMBH-HQ K010203

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other