BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPRESSIX ALGINATE XTRA FASTSET

    MDR report key: 6645287 · Received June 15, 2017

    Report

    Report Number
    1036212-2017-00003
    Event Type
    Injury
    Date Received
    June 15, 2017
    Date of Event
    May 10, 2017
    Report Date
    June 15, 2017
    Manufacturer
    RAINTREE ESSIX INC.
    Product Code
    ELW
    PMA / PMN Number
    K052455
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    EMERGENCY MEDICAL TECHNICIAN

    Narratives

    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. WE HAVE EVALUATED THE BATCH REPORTS AND RETAIN SAMPLES. WE CANNOT FIND ANYTHING UNUSUAL. WE HAVE TO ASSUME THAT THE PATIENT IS SENSITIVE FOR ONE OR MORE OF THE INGREDIENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED AN ALLERGIC REACTION TO IMPRESSIX ALGINATE IMPRESSION MATERIAL. THE PATIENT WAS SENT TO THE ER FOR TREATMENT. ADDITIONAL DETAILS HAVE BEEN REQUESTED, BUT ARE NOT YET AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425144 IMPRESSIX ALGINATE XTRA FASTSET MATERIAL, IMPRESSION ELW RAINTREE ESSIX INC. NA 151001

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Hospitalization