BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENIE

    MDR report key: 1032880 · Received April 23, 2008

    Report

    Report Number
    2248078-2008-00042
    Event Type
    Injury
    Date Received
    April 23, 2008
    Report Date
    March 26, 2008
    Manufacturer
    SULTAN HEALTHCARE
    Product Code
    ELW
    PMA / PMN Number
    K030414
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER THAN AN ALLERGIC REACTION TO THE IMPRESSION MATERIAL, THE EXHIBITED SYMPTOMS COULD BE THE RESULT OF THE FOLLOWING: TRAUMATIC PREPARATION - CROWN PREPARATION CAN BE TRAUMATIC EVEN UNDER IDEAL CIRCUMSTANCES. IN LESS THAN IDEAL CIRCUMSTANCES (VERY LITTLE TOOTH STRUCTURE LEFT, POOR ORAL HYGIENE/HEALTH, POOR OPERATOR CONTROL) SORENESS AND SWELLING COULD BE EXPECTED. TRAUMATIC RETRACTION - RETRACTION CORD PLACEMENT CAN BE TRAUMATIC AND OFTEN RESULTS IN SORENESS AND MINOR SWELLING. IN HEALTHY INDIVIDUALS, THIS IS VERY MINOR. THE POSSIBILITY EXISTS THAT THE PT COULD BE ALLERGIC TO THE RETRACTION MATERIAL, HEMATOSTATIC AGENT OR EVEN THE LATEX GLOVES HANDLING THE CORD. ALLERGY TO TEMPORARY CROWN AND BRIDGE MATERIALS - METHACRYLATE ALLERGIES ARE RARE, BUT COULD EXPLAIN THE OBSERVATIONS. POOR FITTING TEMPORARY RESTORATIONS - A POORLY CONSTRUCTED/FITTED TEMPORARY WILL CAUSE TISSUE SWELLING AND TRAUMA - AND IS QUITE COMMON. STILL, WHILE IT IS UNK IF THE IMPRESSION MATERIAL 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT'S GINGIVAL TISSUE BECAME SORE, INFLAMED, AND SWOLLEN AFTER A CROWN PLACEMENT PROCEDURE DURING WHICH GENIE IMPRESSION MATERIAL WAS USED; THE SAME REACTION OCCURRED DURING A PREVIOUS CROWN PLACEMENT PROCEDURE. THE PT CONSULTED AN ALLERGIST, THOUGH RESULTS OF TESTING ARE NOT AVAILABLE AFTER MULTIPLE UNSUCCESSFUL FOLLOW-UP ATTEMPTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENIE ELW SULTAN HEALTHCARE NA 090925965

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other CEMENTS| OTHER UNK IMPRESSION MATERIALS| BRIDGE MATERIALS| CROWN