BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPREGUM PENTA SOFT QUICK STEP

    MDR report key: 1646618 · Received March 15, 2010

    Report

    Report Number
    9611385-2010-00001
    Event Type
    Injury
    Date Received
    March 15, 2010
    Date of Event
    February 9, 2010
    Report Date
    February 16, 2010
    Manufacturer
    3M ESPE AG
    Product Code
    ELW
    PMA / PMN Number
    K032001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE 3M ESPE IMPRESSION MATERIALS (POSITION PENTA QUICK, IMPREGUM PENTA SOFT QUICK STEP, IMPREGUM SOFT QUICK STEP, AND POLYETHER ADHESIVE) WERE DISCARDED FOLLOWING THE PROCEDURES AND NO SAMPLE OR LOT NUMBER IS AVAILABLE. THE SAMPLE OF PROTEMP PLUS HAS BEEN RETURNED TO THE MFR FOR ANALYSIS. BASED ON CURRENT COMPLAINT HISTORY, REPORTS OF REACTION TO POLYETHER IMPRESSION MATERIALS ARE RARE; APPROX 2 REACTIONS (OF ANY NATURE) ARE REPORTED PER MILLION PRODUCT APPLICATIONS. WHILE THIS NUMBER IS LOW, 3M ESPE AG TAKES ALL ALLEGATIONS SERIOUSLY AND HAS SEARCHED 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 INFO MAY FLOW MORE FREELY BETWEEN DENTISTS THAN FROM DENTIST TO MFR), CHEMICALLY ANALYZING RETURNED PRODUCT WHEN IT IS AVAILABLE, CONDUCTING ADD'L IRRITATION TESTING OF PRODUCT AND COMPONENTS AND REVIEWING PRODUCT COMPOSITION WITH TOXICOLOGY EXPERTS. NO COMMON CAUSE OR FACTOR HAS BEEN IDENTIFIED TO DATE. BASED ON OUR EVAL OF BIOCOMPATIBILITY AND CLINICAL HISTORY, THE PRODUCTS ARE SAFE FOR ITS INTENDED USE. MFR REPORT NUMBERS: 9611385-2010-00002: IMPREGUM SOFT QUICK STEP, 9611385-2010-00003: POSITION PENTA QUICK, 9611385-2010-00004: POLYETHER ADHESIVE, 9611385-2010-00005: PROTEMP PLUS.

    Description of Event or Problem · 1

    FOLLOWING A CROWN PREPARATION PROCEDURE WHICH UTILIZED SEVERAL 3M ESPE PRODUCTS, A PT EXPERIENCED HIVES AND BREATHING DIFFICULTY. THE 3M ESPE PRODUCTS USED INCLUDE: 3M ESPE PROTEMP PLUS TEMPORIZATION MATERIAL, 3M ESPE POSITION PENTA QUICK VINYL POLYSILOXANE PRELIMINARY IMPRESSION MATERIAL, 3M ESPE IMPREGUM PENTA SOFT QUICK SOFT POLYETHER IMPRESSION MATERIAL, 3M ESPE IMPREGUM SOFT QUICK POLYETHER IMPRESSION MATERIAL, AND 3M ESPE POLYETHER ADHESIVE. OTHER NON-3M ESPE PRODUCTS REPORTED TO HAVE BEEN USED IN THE PROCEDURE INCLUDE: SEPTOCAINE, GINGI-PAK SOAKED IN HEMODENT AND TEMP BOND. THE PT SOUGHT TREATMENT AT AN EMERGENCY ROOM; REPORTED TREATMENT INCLUDED ADMINISTRATION OF INTRAVENOUS STEROIDS AND FAMOTIDINE (PEPCID). THE PT WAS RELEASED LATER THE SAME EVENING AND WAS GIVEN A PRESCRIPTION FOR ORAL STEROIDS AND FAMOTIDINE. THE PT IS REPORTED TO BE CURRENTLY IN GOOD CONDITION. NO ADD'L INFO ON THE SITUATION IS AVAILABLE AT THIS TIME; 3M ESPE WILL CONTINUE TO INVESTIGATE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other