BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTEGRITY

    MDR report key: 1163091 · Received September 15, 2008

    Report

    Report Number
    2515379-2008-00090
    Event Type
    Injury
    Date Received
    September 15, 2008
    Report Date
    August 18, 2008
    Manufacturer
    DENTSPLY CAULK
    Product Code
    EBG
    PMA / PMN Number
    K924830
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE IT IS UNKNOWN IF THE INTEGRITY 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 IS REPORTABLE. 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

    IT WAS REPORTED THAT A PT DEVELOPED ULCERS UNDER THE LIP AND SWELLING OF THE FACE AND LIPS THE NIGHT AFTER PLACEMENT OF TWELVE RESTORATIONS USING INTEGRITY. THE PT WAS ADMINISTERED CORTISONE AND BENADRYL AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRITY EBG DENTSPLY CAULK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention