BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 813055 · Received February 5, 2007

    Report

    Report Number
    MW1041862
    Event Type
    Malfunction
    Date Received
    February 5, 2007
    Date of Event
    January 3, 2007
    Report Date
    February 5, 2007
    Manufacturer
    HENRY SCHEIN
    Product Code
    ELW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    EXTREMELY POOR/MISLEADING LABELING OF PACKAGE RESULTED IN INAPPROPRIATE USE. MATERIAL IN QUESTION - ITEM CODE: 1007001 MANUFACTURER: HENRY SCHEIN INC. #0182147011 -- PG 357 OF 2005 CATALOGUE -- IS TO BE USED SOLEY AS ALGINATE/IRREVERSIBLE HYDROCOLLOID ADHESIVE. -WATER BASED PROUCTS ONLY-, LABELING IS MISLEADING AND HAS IN FACT RESULTED IN USE WITH SILICONE BASED IMPRESSIONS MATERIALS FOR EXTENDED PERIOD OF TIME BY MULTIPLE PROVIDERS IN AT LEAST ONE CLINIC. RESULT HAS BEEN CLINICAL FAILURE AND NUMEROUS DEBONDINGS/LOSS OF COST OF IMPRESSION MATERIAL FROM TRAYS DURING EACH PROCEDURE. MATERIAL SPECIFIC ADHESIVES ARE REQUIRED. PACKAGING ON BOTTLE DOES NOT SPECIFY MATERIALS THIS ADHESIVE IS TO BE USED WITH. IT SIMPLY AND GENERICALLY STATES "ADHESVIE" IF ONE DOES NOT HAVE A CATALOGUE AVAILABLE THERE IS NO WAY TO IDENTIFY DURING CLINICAL USE THAT MATERIAL IS SUITABLE ONLY FOR ALGINATE AND THE CORRECT SCHEIN PRODUCT IS "V.P.S. ADHESIVE" - -PN; 100-1765-. THIS DEFICIENCY WAS FIRST RECOGNIZED WHEN I REQUESTED NEW BOTTLE OF ADHESIVE AND IN VERY SAMLL LETTERING ON EXTERNAL CARDCARD BOX I NOTICED INTENDED MATERIALS FOR USE SPECIFIED...STORAGE AND USE CLINICALLY DOES NOT OFTEN MAINTAIN OUTER BOX ONCE PRODUCT IS FIRST USED IN A CLINIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * TRAY ADHESIVE 1OZ/BT ELW HENRY SCHEIN 1007001 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *