BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 966822 · Received October 6, 2006

    Report

    Report Number
    2110898-2006-00012
    Event Type
    Malfunction
    Date Received
    October 6, 2006
    Report Date
    October 5, 2006
    Manufacturer
    3M COMPANY
    Product Code
    EBI
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: ONE BOTTLE OF Z100 CAPSULES, 5905A2, LOT 6KX, EXPIRATION DATE 04/09, WAS RETURNED TO 3M ESPE DENTAL PRODUCTS. THE BOTTLE CONTAINED THE REMAINING CAPSULES WITH UNATTACHED DAMAGED HUMECTANT DISC AND LOOSE SILICA GEL. THE HUMECTANT CONTAINING DISC IS ADDED TO THE BOTTLES OF CAPSULES TO HELP MAINTAIN PRODUCT SHELF LIFE. THE ENGINEERING EVALUATION OF THE RETURNED SAMPLE SHOWS THAT THERE WAS A FAILURE FOR THIS HUMECTANT DISC. THIS IS THE FIRST ALLEGATION OF THIS TYPE THAT HAS BEEN REC'D. AN EVALUATION OF THE HUMECTANT PRIOR TO INTRODUCTION INTO THE BOTTLES SHOWED THAT BREAKING OF THE HUMECTANT DISC WAS UNLIKELY, BUT THAT IF IT OCCURRED AND THE CONTENTS WERE RELEASED, NO ADVERSE HEALTH EFFECTS WERE ANTICIPATED. RESULTS - PACKAGING RELATED. INTEGRITY FAILURE OF THE HUMECTANT DISC PROVIDED IN THE PACKAGING. CONCLUSIONS - PACKAGING RELATED. INTEGRITY FAILURE OF THE HUMECTANT DISC PROVIDED IN THE PACKAGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * EBI 3M COMPANY

    Patients

    Seq Age Sex Outcome Treatment
    1