BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IRM ZOE INTERMEDIATE RESTORATIVE MATERIAL

    MDR report key: 4860145 · Received June 18, 2015

    Report

    Report Number
    8010638-2015-00006
    Event Type
    Injury
    Date Received
    June 18, 2015
    Date of Event
    May 11, 2015
    Report Date
    May 20, 2015
    Manufacturer
    DENTSPLY CAULK
    Product Code
    EMA
    PMA / PMN Number
    PREAMENDM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    MULTIPLE UNSUCCESSFUL ATTEMPTS WERE MADE TO OBTAIN THE DEVICE FOR EVALUATION. RETAIN PRODUCT WAS TESTED AND FOUND TO BE WITHIN SPECIFICATION.

    Additional Manufacturer Narrative · 1

    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 RESULTS ARE NOT AVAILABLE AS OF THIS REPORT. EVALUATION RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.

    Description of Event or Problem · 1

    IN THIS EVENT IT WAS REPORTED THAT A PATIENT EXPERIENCED AN ALLERGIC REACTION AFTER THE USE OF IRM CEMENT. THE PATIENT DEVELOPED A COUGH, WHICH WORSENED AND THEN HAD DIFFICULTY BREATHING. THE PATIENT SAW HER DOCTOR WHO PRESCRIBED AN ANTIHISTAMINIC DRUG. THE PATIENT HAS SINCE RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397129 IRM ZOE INTERMEDIATE RESTORATIVE MATERIAL DENTAL CEMENT EMA DENTSPLY CAULK 1307000087

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention