BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYGENIC

    MDR report key: 8731711 · Received June 25, 2019

    Report

    Report Number
    2416455-2019-00002
    Event Type
    Injury
    Date Received
    June 25, 2019
    Report Date
    July 1, 2019
    Manufacturer
    COLTENE WHALEDENT INC.
    Product Code
    EIE
    UDI-DI
    D661H091051
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    ON 6/27/2019 COLTENE WAS MADE AWARE THAT THE PRODUCT INVOLVED IN THE ADVERSE EVENT WAS NOT A COLTENE PRODUCT. THIS MEDICAL DEVICE REPORT CAN BE VOIDED.

    Description of Event or Problem · 1

    AN ALLERGIC REACTION OCCURED AFTER AN OFFICE VISIT FOLLOWING THE USE OF A NON-LATEX DENTAL DAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    524891 HYGENIC DENTAL DAM EIE COLTENE WHALEDENT INC. D661H091051

    Patients

    Seq Age Sex Outcome Treatment
    1 Other