BEUDAMED
    FDA Adverse Event Other Summary report: N

    IMPREGUM PENTA SOFT

    MDR report key: 787019 · Received June 20, 2006

    Report

    Report Number
    9611385-2006-00007
    Event Type
    Other
    Date Received
    June 20, 2006
    Report Date
    May 19, 2006
    Manufacturer
    3M ESPE AG
    Product Code
    ELW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    CHEMICAL AND PERFORMANCE ANALYSIS OF PRODUCT WAS LIMITED IN THIS CASE BY THE LACK OF A RETURNED SAMPLE. 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 HOSPITAL 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING OR AFTER A DENTAL IMPRESSION PROCEDURE WITH IMPREGUM PENTA SOFT, MANUFACTURED BY 3M ESPE AG, THE PATIENT EXPERIENCED SWELLING OF THE TONGUE AND THROAT. INFORMATION ON THE TIME COURSE FOR THE ONSET OF THE SYMPTOMS WAS NOT PROVIDED TO 3M ESPE. REPORTEDLY, THE PATIENT IMMEDIATLY WAS ADMITTED FROM THE DENTAL OFFICE WHERE HE RECEIVED THE DENTAL TREATMENT TO HOSPITAL. BACKGROUND INFORMATION ON THE HOSPITAL STAY AND INFORMATION ON MEDICAL TREATMENT WAS NOT PROVIDED TO 3M ESPE. ACCORDING TO OUR INFORMATION, HE BECAME BETTER DURING THE DAY AND LEFT THE HOSPITAL THE SAME DAY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization