BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPREGUM PENTA

    MDR report key: 853151 · Received May 16, 2007

    Report

    Report Number
    9611385-2007-00001
    Event Type
    Injury
    Date Received
    May 16, 2007
    Date of Event
    March 16, 2007
    Report Date
    April 20, 2007
    Manufacturer
    3M ESPE AG
    Product Code
    ELW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CHEMICAL AND PERFORMANCE ANALYSIS OF THE PRODUCT INVOLVED IN THIS SITUATION IS UNDERWAY; SAMPLES FOR ANALYSIS WERE RECEIVED BY 3M ESPE ON MAY 14, 2007. HOWEVER, BATCH RECORDS FOR THE LOT NUMBER REPORTED INDICATE THAT THE PRODUCT WAS WITHIN SPECIFICATION AT PRODUCT RELEASE. THE PATIENT IS REPORTED TO BE ALLERGIC TO NICKEL SULPHATE AND POSSIBLY POLYETHER COMPONENTS. NICKEL SULPHATE IS NOT A COMPONENT OF IMPREGUM PENTA. BASED ON CURRENT COMPLAINT HISTORY, REPORTS OF REACTION TO POLYETHER IMPRESSION MATERIALS ARE RARE; APPROXIMATELY 2 REACTIONS (OF ANY NATURE) ARE REPORTED PER MILLION PRODUCT APPLICATIONS. WHILE THIS NUMBER IS LOW, 3M ESPE AG TAKES ALL ALLEGATIONS SERIOUSLY AND CONTINUES TO SEARCH FOR ROOT CAUSES OR CONTRIBUTING FACTORS THAT MAY HAVE LED TO A REACTION. ACTIONS TAKEN TO DATE TO IDENTIFY POTENTIAL CAUSES INCLUDE: COOPERATING WITH A DENTAL UNIVERSITY TO CONDUCT DENTIST-TO-DENTIST FOLLOW-UP OF REACTION ALLEGATIONS (OUR EXPERIENCE INDICATES THAT INFORMATION MAY FLOW MORE FREELY BETWEEN DENTISTS THAN FROM DENTIST TO MANUFACTURER), CHEMICALLY ANALYZING RETURNED PRODUCT WHEN IT IS AVAILABLE, CONDUCTING ADDITIONAL IRRITATION TESTING OF PRODUCT AND COMPONENTS AND REVIEWING PRODUCT COMPOSITION WITH TOXICOLOGY EXPERTS. NO COMMON CAUSE OR FACTORS HAS BEEN IDENTIFIED TO DATE. AN ALLERGY TEST USING A TEST PROTOCOL THAT WAS DEVELOPED BETWEEN THE DENTAL AND THE DERMATOLOGICAL FACULTY OF THE UNIVERSITY, WILL BE CARRIED OUT WITH THE PATIENT TO RECEIVED MORE VALID INFORMATION ON POTENTIAL CAUSES FOR THE REPORTED ADVERSE EVENT. D4: ADD'L LOT # 249865.

    Description of Event or Problem · 1

    IT IS REPORTED THAT 3-5 HOURS AFTER TWO DENTAL IMPRESSIONS WERE TAKEN WITH IMPREGUM PENTA, MANUFACTURED BY 3M ESPE AG, THE PATIENT EXPERIENCED ITCHING AND BLISTERS AT THE CONTACT AREA. TEN TO TWELVE HOURS AFTER THE IMPRESSION PROCEDURE, THE PATIENT REPORTEDLY FELT DIZZY AND SUFFERED SWELLING IN THE MOUTH, DIFFICULTY IN SWALLOWING AND BREATHING. IT WAS REPORTED THAT AN EMERGENCY DOCTOR TREATED THE PATIENT WITH CORTISONE. THE SYMPTOMS SUBSIDED 10 MIN AFTER CORTISONE APPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMPREGUM PENTA POLYETHER BASED DENTAL IMPRESSION MATERIAL ELW 3M ESPE AG NA 249191

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other