BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPREGUM PENTA

    MDR report key: 1058648 · Received June 9, 2008

    Report

    Report Number
    9611385-2008-00004
    Event Type
    Injury
    Date Received
    June 9, 2008
    Report Date
    May 9, 2008
    Manufacturer
    3M ESPE AG
    Product Code
    ELW
    PMA / PMN Number
    K992897
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT RETURNED TO 3M; THEREFORE, NO EVALUATION WAS CONDUCTED. NO RESULTS OR CONCLUSIONS CAN BE DRAWN. 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 CONTINUE 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 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 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 PT TO RECEIVE MORE VALID INFO ON POTENTIAL CAUSES FOR THE REPORTED ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED IN MAY 2008 THAT A FEMALE PT SUFFERED FACE SWELLING (FROM LIPS TO EYES) IMMEDIATELY AFTER IMPRESSIONS WERE TAKEN WITH IMPRESSIONS MATERIALS. THE DENTIST TERMED THE SYMPTOMS AS QUINCKE'S OEDEMA. BASED ON INFO, THE PT RECEIVED INFUSIONS FOR ONE WEEK. IMPRESSION MATERIALS: IMPREGUM PENTA (THIS CASE) & PERMADYNE GARANT 2:1 (PLEASE REFER TO CASE NUMBER 9611385-2008-00005).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization| O