BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3M ESPE IMPREGUM PENTA SOFT

    MDR report key: 1393117 · Received May 20, 2009

    Report

    Report Number
    9611385-2009-00006
    Event Type
    Injury
    Date Received
    May 20, 2009
    Report Date
    April 23, 2009
    Manufacturer
    3M ESPE AG
    Product Code
    ELW
    PMA / PMN Number
    K954192
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS AND CONCLUSIONS: DEVICE WAS NOT RETURNED TO 3M ESPE, THEREFORE, NO EVALUATION WAS CONDUCTED. THE 3M ESPE IMPREGUM PENTA SOFT ITSELF IS NOT SOLD IN THE US. A PRODUCT VERY SIMILAR TO IMPREGUM PANTA SOFT IS MARKETED IN THE US UNDER THE PRODUCT NAME IMPREGUM PENTA SOFT MEDIUM BODY. THE CHEMICAL COMPOSITION OF BASE PASTE OF IMPREGUM PENTA SOFT AND IMPREGUM PENTA SOFT MEDIUM BODY IS IDENTICAL, WHEREAS THE CHEMICAL COMPOSITIONS OF THE CATALYST PASTE OF BOTH PRODUCTS ARE SLIGHTLY DIFFERENT. BECAUSE, OF THE SIMILARITY IN CHEMISTRY BETWEEN THESE TWO PRODUCTS, THIS REPORT IS BEING MADE TO THE FDA EVEN THOUGH THE SPECIFIC PRODUCT IS NOT ON THE US MARKET. 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. BASED ON OUR EVACUATION OF BIOCOMPATIBILITY AND CLINICAL HISTORY, THE PRODUCT IS SAFE FOR ITS INTENDED USE.

    Description of Event or Problem · 1

    IN 2009, A DENTIST INFORMED 3M SWITZERLAND THAT A FEMALE PATIENT SUFFERED RASH OF THE FACE AND SWELLING AFTER IMPRESSIONS WERE TAKEN WITH 3M ESPE IMPREGUM PENTA SOFT. THE PATIENT WAS HOSPITALIZED FOR TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3M ESPE IMPREGUM PENTA SOFT POLYETHER IMPRESSION MATERIAL ELW 3M ESPE AG UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O