BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3M ESPE POLYETHER ADHESIVE

    MDR report key: 3310620 · Received August 7, 2013

    Report

    Report Number
    9611385-2013-00013
    Event Type
    Injury
    Date Received
    August 7, 2013
    Date of Event
    May 22, 2013
    Report Date
    June 27, 2013
    Manufacturer
    3M DEUTSCHLAND GMBH
    Product Code
    EBH
    PMA / PMN Number
    K875228
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    AS NOTED IN THE EVENT DESCRIPTION OF THIS REPORT, THREE SUSPECT DEVICES WERE INVOLVED IN THE CURRENT EVENT, THEREFORE, THIS REPORT INCLUDES THE THIRD SUSPECT DEVICE AND THE OTHER TWO SUSPECT DEVICE DESCRIPTIONS ARE INCLUDED IN MFR REPORT NUMBERS 9611385-2013-00011 AND 9611385-2013-00012, RESPECTIVELY. THE SUSPECT DEVICE NOTED IN THIS REPORT HAS NOT BEEN RETURNED TO 3M ESPE. THE ANALYSIS OF A RETAINED SAMPLE OF THE SAME LOT SHOWED NO PARTICULARITY. THIS PRODUCT HAS BEEN ASSESSED FOR BIOCOMPATIBILITY AND HAS BEEN FOUND TO BE SAFE FOR ITS INTENDED USE. THE DENTIST STATED THAT THERE WAS ALREADY AN INTOLERANCE REACTION WHEN THE PRODUCTS WERE APPLIED TO THE PT IN THE YR 1996, BUT AT THIS TIME THERE WERE ONLY MILD SYMPTOMS. THEREFORE, IT CAN BE ASSUMED, THAT THERE'S UNDERLYING ALLERGIC REACTION. THIS TIME THE SYMPTOMS WERE ALSO NOT LIFE-THREATENING, BUT RATED AS SEVERE BY THE DENTIST.

    Description of Event or Problem · 1

    AFTER A DENTAL IMPRESSION USING THE 3M ESPE PRODUCTS 3M ESPE PERMADYNE H, 3M ESPE PERMADYNE L, AND 3M ESPE POLYETHER ADHESIVE A PT SUFFERED FROM STRONG SWELLING AND REDDENING IN THE AREAS OF THE NECK AND THE CHEEKS. ADDITIONALLY SHE HAD A NUMB FEELING IN THE TONGUE. ALL SYMPTOMS VANISHED AFTER THREE DAYS. THE SYMPTOMS WERE RATED SERIOUS BY THE DENTIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371369 3M ESPE POLYETHER ADHESIVE POLYETHER ADHESIVE EBH 3M DEUTSCHLAND GMBH 490285

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other