BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CALIBRA VEN TRY-IN 1.8GM LT RF

    MDR report key: 17194364 · Received June 23, 2023

    Report

    Report Number
    2515379-2023-00082
    Event Type
    Malfunction
    Date Received
    June 23, 2023
    Report Date
    October 26, 2023
    Manufacturer
    DENTSPLY LLC
    Product Code
    EMA
    UDI-DI
    D0026073011
    PMA / PMN Number
    K040906
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: PRODUCT WAS EXPIRED FIVE YEARS AGO. NOT ABLE TO INVESTIGATE. PRODUCT EXPIRED IN 2018. COMPLAINT WAS SUBMITTED IN 2023. NO DEFECT PROVEN.

    Additional Manufacturer Narrative · 0

    WHILE IT IS UNKNOWN IF THE DEVICE USED IN THIS CASE CAUSED OR CONTRIBUTED TO THE PATIENT¿S SYMPTOMS, IT IS POSSIBLE AS ALLERGIC REACTIONS TO DENTAL MATERIALS ARE KNOWN AND REPORTED, WITH MEDICAL CONSEQUENCES BEING DEPENDENT UPON THE SEVERITY OF THE INDIVIDUAL ALLERGIC RESPONSE AND SUBSEQUENT EXPOSURE TO THE SAME MATERIAL. THEREFORE, THIS EVENT MEETS THE CRITERIA FOR REPORTABILITY PER 21 CFR PART 803. THE DEVICE IS AVAILABLE FOR EVALUATION, THOUGH HAS NOT BEEN RETURNED AS OF THIS REPORT. EVALUATION RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.

    Description of Event or Problem · 0

    IN THIS EVENT IT IS REPORTED THAT CALIBRA VEN TRY-IN 1.8GM LT RF THAT WAS USED ALLEGEDLY CAUSED A IRRIATIATION REACTION TO A PATIENT. NO INJURY REPORTED. FURTHER INFORMATION REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1758098 CALIBRA VEN TRY-IN 1.8GM LT RF CEMENT, DENTAL EMA DENTSPLY LLC 607301 1612141 D0026073011

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown