BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HENRY SCHEIN PRESSURE INDICATING PASTE

    MDR report key: 3855176 · Received May 30, 2014

    Report

    Report Number
    2515379-2014-00031
    Event Type
    Injury
    Date Received
    May 30, 2014
    Date of Event
    March 1, 2012
    Report Date
    April 30, 2014
    Manufacturer
    DENTSPLY CAULK
    Product Code
    EFH
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE IT IS UNKNOWN IF THE DEVICE USED IN THIS CASE CAUSED OR CONTRIBUTED TO THE PT'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 EVAL 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 PT EXPERIENCED AN ALLERGIC REACTION AFTER USING HENRY SCHEIN PRESSURE INDICATING PASTE. ACCORDING TO THE DOCTOR, THE PT WAS TREATED IN (B)(6) 2012 FOR A PROCEDURE USING THE PRESSURE INDICATING PASTE. IMMEDIATELY AFTER THE TREATMENT, THE CUSTOMER DEVELOPED A RED MARK ON HER LIP WHICH IS STILL PRESENT. THE PT HAS BEEN SEEING A DERMATOLOGIST SINCE (B)(6) 2012 AND RECENTLY HAD A BIOPSY DONE TO DETERMINE WHAT CHEMICAL SHE IS REACTING TO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319776 HENRY SCHEIN PRESSURE INDICATING PASTE ARTICULATION PAPER EFH DENTSPLY CAULK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other