BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IPS E.MAX PRESS LT

    MDR report key: 6878727 · Received September 20, 2017

    Report

    Report Number
    9612352-2017-00003
    Event Type
    Injury
    Date Received
    September 20, 2017
    Date of Event
    December 2, 2016
    Report Date
    September 18, 2017
    Manufacturer
    IVOCLAR VIVADENT, AG
    Product Code
    EIH
    PMA / PMN Number
    K982616
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT DID NOT RETURN THE DEVICE.

    Description of Event or Problem · 1

    PATIENT CONTACTED IVOCLAR VIVADENT ON AUGUST 17, 2017 WITH A COMPLAINT ABOUT A POSSIBLE ALLERGIC REACTION FROM AN IPS E.MAX RESTORATION. THE PATIENT REPORTED THAT FOLLOWING THE PLACEMENT OF AN IPS E.MAX RESTORATION ON (B)(6) 2016, SHE RETURNED TO THE DENTIST AND THE DENTIST RECOMMENDED ROOT CANAL THERAPY. THE PATIENT BELIEVED HER PROBLEMS WERE CAUSED BY AN ALLERGIC REACTION TO THE CROWN. ON (B)(6) 2017, THE PATIENT REQUESTED THAT THE DOCTOR REMOVE THE CROWN AND REPLACE IT WITH ANOTHER MATERIAL. THE DOCTOR DECLINED THE REQUEST AND REFERRED HER FOR ENDO. THE ENDODONTIST CONFIRMED THAT SHE NEEDED A ROOT CANAL, BUT THE PATIENT DID NOT FEEL IT WAS NECESSARY AND BELIEVED SHE WAS SUFFERING AN ALLERGIC REACTION. THE PATIENT PROVIDED AN ALLERGY LIST TO IVOCLAR VIVADENT ON AUGUST 28, 2017. THE LIST WAS CROSS CHECKED WITH IPS E.MAX INGREDIENTS. IVOCLAR VIVADENT, AG CONFIRMED ON AUGUST 29, 2017 THAT NONE OF THE ALLERGIES LISTED WERE CONTAINED IN IPS E.MAX. DURING A FOLLOW-UP CONVERSATION ON SEPTEMBER 14, 2017 THE CUSTOMER CONFIRMED TO IVOCLAR THAT SHE HAD THE CROWN REMOVED AND A ROOT CANAL WAS PERFORMED. THE PATIENT IS CURRENTLY IN A TEMPORARY RESTORATION, AND STATED THAT HER SYMPTOMS HAD GONE AWAY. THE PATIENT STATES SHE HAD ADDITIONAL ALLERGY TESTING DONE AND THE REPORT SHOWS SHE IS ALLERGIC TO IPS E.MAX. THE ADDITIONAL ALLERGY TEST REPORT HAS NOT BEEN SUBMITTED FOR IVOCLAR VIVADENT TO REVIEW. IT IS BELIEVED BY THE ORIGINAL DENTIST WHO TREATED HER THAT SHE REQUIRED ENDODONTIC TREATMENT AND THAT HER SYMPTOMS WERE NOT RELATED TO AN ALLERGIC REACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660579 IPS E.MAX PRESS LT POWDER, PORCELAIN EIH IVOCLAR VIVADENT, AG

    Patients

    Seq Age Sex Outcome Treatment
    1 Other