BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IRM ZOE INTERMEDIATE RESTORATIVE MATERIAL

    MDR report key: 739334 · Received July 21, 2006

    Report

    Report Number
    2515379-2006-00333
    Event Type
    Injury
    Date Received
    July 21, 2006
    Date of Event
    June 21, 2006
    Report Date
    June 21, 2006
    Manufacturer
    DENTSPLY CAULK
    Product Code
    EBF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE IT IS UNKNOWN IF THE IRM 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 IS REPORTABLE PER 21 CFR PART 803. THE DEVICE WAS NOT RETURNED FOR EVALUATION AND THE LOT NUMBER IS NOT KNOWN FOR RETAINED-PRODUCT TESTING AND/OR DHR REVIEW.

    Description of Event or Problem · 1

    A PATIENT CONTACTED THE TREATING CLINICIAN SHORTLY AFTER PLACEMENT OF AN IRM ZINC OXIDE EUGENOL RESTORATION, COMPLAINING OF "BLOTCHY REDNESS" ON THE FOREARM. THE DOCTOR RECOMMENDED THAT THE PATIENT TAKE BENADRYL TO TREAT THE SYMPTOMS AND IT WAS REPORTED THAT THE SYMPTOMS DID NOT WORSEN, THOUGH THE PATIENT OPTED TO TAKE ONLY ONE TAB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IRM ZOE INTERMEDIATE RESTORATIVE MATERIAL EBF EBF DENTSPLY CAULK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other