BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERMADYNE HEAVY BODY

    MDR report key: 1348649 · Received March 13, 2009

    Report

    Report Number
    9611385-2009-00003
    Event Type
    Injury
    Date Received
    March 13, 2009
    Date of Event
    January 30, 2009
    Report Date
    February 12, 2009
    Manufacturer
    3M ESPE AG
    Product Code
    ELW
    PMA / PMN Number
    K800031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD, RESULTS AND CONCLUSIONS: RESULTS OF INVESTIGATION OF RETURNED SAMPLE SHOWED THAT THE DEVICE WAS WITHIN PRODUCT SPECIFICATION. ALLERGY REACTIONS TO POLYETHER IMPRESSION MATERIALS COULD BE THE REASON FOR THE SYMPTOMS THAT THIS PATIENT EXPERIENCED SIMILAR SYMPTOMS APPROXIMATELY 12 YEARS AGO, AFTER A DENTAL PROCEDURE USING ANOTHER POLYETHER IMPRESSION MATERIAL. 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 A DENTAL UNIVERSITY 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. SEE SCANNED PAGES.

    Description of Event or Problem · 1

    ON 02/12/2009, A FEMALE PATIENT REPORTED TO 3M ESPE DENTAL PRODUCTS, SHE EXPERIENCED SWELLING AND TINGLING IN HER LIPS, IN THE EVENING, FOLLOWING AN IMPRESSION TAKEN IN 2009 WITH 3M ESPE PERMADYNE HEAVY BODY. PRIOR TO THE PROCEDURE, SHE TOOK PREDNISONE. UPON APPEARANCE OF THE SYMPTOMS, SHE TOOK ANOTHER PREDNISONE. THE NEXT DAY, HER SYMPTOMS PROGRESSED TO INCLUDED FACIAL SWELLING, AND LESIONS/BLISTERS INSIDE HER UPPER LIP, AND IN BACK OF HER THROAT. DURING THE NIGHT, SHE WOKE WITH DIFFICULTY SWALLOWING, AND CONTINUED FACIAL SWELLING. SHE THEN GAVE HERSELF AN EPIPEN INJECTION AND WENT TO EMERGENCY ROOM WHERE SHE RECEIVED AN IV AND BREATHING TREATMENT, (NO FURTHER DETAILS ABOUT EMERGENCY ROOM VISIT WERE PROVIDED BY PATIENT TO 3M ESPE). THE PATIENT REPORTED THAT SHE STAYED IN THE HOSPITAL UNTIL THE NEXT MORNING. THE PATIENT REPORTED THAT IT TOOK ABOUT 7 DAYS FOR THE SWELLING TO TOTALLY SUBSIDE, AND THAT SHE WAS NOW BACK TO NORMAL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L