BEUDAMED
    FDA Adverse Event Other Summary report: N

    HENRY SCHEIN NATURAL ELEGANCE FLOWABLE

    MDR report key: 1981272 · Received February 2, 2011

    Report

    Report Number
    1721729-2010-00002
    Event Type
    Other
    Date Received
    February 2, 2011
    Date of Event
    December 23, 2010
    Report Date
    January 28, 2011
    Manufacturer
    SEPTODONT CONFI-DENTAL DIVISION
    Product Code
    EBF
    PMA / PMN Number
    954988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT HAS BEEN USED IN DENTISTRY FOR MANY YEARS. TO DATE, WE HAVE NEVER HAD ANOTHER COMPLAINT OR REPORT OF BREATHING COMPLICATIONS ASSOCIATED WITH THIS PRODUCT. THE CUSTOMER, (B)(6), INDICATED THAT "ANY RETURNED PRODUCT¿ WILL BE SHIPPED TO YOU UNDER SEPARATE COVER." AS OF THE DATE OF SUBMISSION OF THIS REPORT, SAMPLES OF THE SUSPECT PRODUCT HAD NOT BEEN RECEIVED FOR EVAL AND COMPLAINT (B)(4) REMAINS OPEN AWAITING EVAL OF THE ACTUAL PRODUCT USED.

    Description of Event or Problem · 1

    MALE PT (BIRTH DATE (B)(6)) EXPERIENCED BREATHING COMPLICATIONS 5 HOURS AFTER A DENTAL PROCEDURE INVOLVING NATURAL ELEGANCE FLOWABLE COMPOSITE DENTAL FILLING MATERIAL. WENT TO HOSPITAL BUT WAS FINE AND THEY DID NOT ADMINISTER ANY MEDICATION. THEY ARE NOT REALLY SURE THAT THIS PRODUCT DID CAUSE THE BREATHING PROBLEM. THIS INFO IS FROM (B)(6). ADVERSE EVENT FORM ((B)(4)). E-MAILED TO CONFI-DENTAL ON (B)(4) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HENRY SCHEIN NATURAL ELEGANCE FLOWABLE DENTAL COMPOSITE FILLING MATERIAL EBF SEPTODONT CONFI-DENTAL DIVISION E9220-1

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Hospitalization