BEUDAMED
    FDA Adverse Event Other Summary report: N

    IMPREGUM PENTA SOFT

    MDR report key: 607833 · Received May 13, 2005

    Report

    Report Number
    9611385-2005-00001
    Event Type
    Other
    Date Received
    May 13, 2005
    Date of Event
    January 1, 2005
    Report Date
    April 22, 2005
    Manufacturer
    3M ESPE AG
    Product Code
    ELW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING TWO SUBSEQUENT IMPRESSION PROCEDURES, THE PATIENT EXPERIENCED SEVERE ALLERGIC REACTIONS IN THE MOUTH REGION. IT WAS REPORTED THAT AFTER THE SECOND PROCEDURE, MASSIVE SWELLING IN THE MOUTH AND THROAT OCCURRED AND THAT THE PATIENT HELPED TO KEEP PATIENT'S AIRWAY OPEN DURING THE NIGHT BY USING A SPOON. THE PATIENT DID NOT CONTACT A PHYSICIAN OR SEEK EMERGENCY TREATMENT; INSTEAD, PATIENT SAW AN ALLERGIST AT A LATER POINT IN TIME. IT WAS THE ALLERGIST WHO INFORMED 3M ESPE AG OF THE INCIDENT. AT THIS TIME, NO CONTACT WITH THE PATIENT OR THE DENTAL OFFICE HAS OCCURRED.

    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 60 YR Other