BEUDAMED
    FDA Adverse Event Other Summary report: N

    IMPREGUM PENTA

    MDR report key: 726238 · Received June 12, 2006

    Report

    Report Number
    9611385-2006-00006
    Event Type
    Other
    Date Received
    June 12, 2006
    Report Date
    May 10, 2006
    Manufacturer
    3M ESPE AG
    Product Code
    ELW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    CHEMICAL AND PERFORMANCE ANALYSIS OF PRODUCT WAS LIMITED TO THIS CASE BY THE LACK OF A RETURNED SAMPLE. 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 CONTINUES TO SEARCH FOR ROOT CAUSE OR CONTRIBUTING FACTORS THAT MAY HAVE LED TO A REACTION. ACTIONS TAKEN TO DATE TO IDENTIFY POTENTIAL CAUSES INCLUDE: COOPERATING WITH A DENTAL UNIV TO CONDUCT DENTIST-TO-DENTIST FOLLOW-UP OF REACTION ALLEGATIONS (CO'S EXPERIENCE INDICATES THAT INFO MAY FLOW MORE FREELY BETWEEN DENTISTS THAN FROM DENTIST TO MFR), CHEMICALLY ANALZING 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 IS REPORTED THAT AFTER A DENTAL INPRESSION PROCEDURE WITH IMPREGUM PENTA IMPRESSION MATERIAL THE PT EXPERIENCED SWELLING OF TONGUE AND GINGIVA. IT IS FURTHER REPORTED THAT THE PT WAS ADMITTED TO HOSP WHERE HE STAYED OVER NIGHT. NO INFO ABOUT MED TREATMENT IS CURRENTLY KNOWN BY 3M ESPE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization