BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIME & BOND NT

    MDR report key: 4017566 · Received August 13, 2014

    Report

    Report Number
    2515379-2014-00046
    Event Type
    Injury
    Date Received
    August 13, 2014
    Report Date
    July 14, 2014
    Manufacturer
    DENTSPLY CAULK
    Product Code
    KLE
    PMA / PMN Number
    K050386
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE IT IS UNKNOWN IF THE DEVICES 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 A DENTIST REPORTED THAT A PATIENT HAD EXPERIENCED AN ALLERGIC REACTION AFTER USING SEVERAL DENTSPLY PRODUCTS. THE DENTIST STATED THAT A DENTAL IMPRESSION WAS TAKEN WITH JELTRATE CHROMA THREE WEEKS EARLIER AND THE PATIENT DID WELL. THE PATIENT RETURNED FOR A CROWN AND BRIDGE THREE WEEKS AFTER HAVING THE IMPRESSION TAKEN. DURING THIS APPOINTMENT TPH SPECTRA AND PRIME AND BOND NT WERE USED, AMONG OTHER NON-DENTSPLY PRODUCTS. THE NEXT DAY THE PATIENT'S LIPS BECAME SWOLLEN AND WHITE. THE PATIENT TOOK AN OTC ALLERGY MEDICINE TO COMBAT THE REACTION. THE DAY AFTER TAKING THE MEDICATION, THE PATIENT WOKE UP AND HER LIPS WERE SWOLLEN WORSE THAN THE DAY BEFORE, SO SHE TOOK MORE OTC ALLERGY MEDICINE. AT 4 O'CLOCK THAT DAY THE PATIENT CONTACTED HER DENTIST BECAUSE HER SYMPTOMS DID NOT GET BETTER. THE DENTIST DIRECTED HER TO SEEK MEDICAL ATTENTION. THE PATIENT WENT TO THE ER, WHERE THEY ADMINISTERED PREDNISONE. THE SYSTEMS ABATED AFTER RECEIVING THE PREDNISONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    483094 PRIME & BOND NT AGENT TOOTH BONDING, RESIN KLE DENTSPLY CAULK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention