BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTOMATRIX BAND

    MDR report key: 3030626 · Received March 21, 2013

    Report

    Report Number
    2515379-2013-00005
    Event Type
    Injury
    Date Received
    March 21, 2013
    Report Date
    February 25, 2013
    Manufacturer
    DENTSPLY CAULK
    Product Code
    DZN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    DENTIST

    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. THE DEVICE WAS NOT RETURNED FOR EVALUATION AND THE LOT NUMBER WAS NOT PROVIDED FOR RETAINED-PRODUCT TESTING AND/OR DHR REVIEW.

    Description of Event or Problem · 1

    IN THIS EVENT, IT WAS REPORTED THAT A PATIENT MAY HAVE EXPERIENCED AN ADVERSE REACTION AFTER UNDERGOING A DENTAL PROCEDURE THAT INVOLVED THE USE OF THE AUTOMATRIX RETAINING BAND AS WELL AS OTHER MATERIALS; NO MEDICAL INTERVENTION WAS NECESSARY. THE PATIENT EXHIBITED SYMPTOMS INCLUDING A SWOLLEN LIP. THE PATIENT RETURNED TO THE DENTAL OFFICE ONE WEEK LATER AND REPORTED THAT HE SAW AN ALLERGIST IN RELATION TO THE SYMPTOMS EXPERIENCED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117768 AUTOMATRIX BAND DZN DENTSPLY CAULK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other