BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUIDOR

    MDR report key: 5869020 · Received August 11, 2016

    Report

    Report Number
    0001413787-2016-00002
    Event Type
    Injury
    Date Received
    August 11, 2016
    Date of Event
    July 18, 2016
    Report Date
    August 11, 2016
    Manufacturer
    DEGRADABLE SOLUTIONS AG
    Product Code
    LYC
    UDI-DI
    07640164360096
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    DOCTOR HAD PLACED THE PRODUCT IN A PREMOLAR THAT WAS MISSING A BONY WALL. AFTER TWO WEEKS THE PATIENT CONTACTED THE DOCTOR AND INFORMED HIM THAT THE SITE IS SWOLLEN & INFECTED. PATIENT WAS IN A LOT OF PAIN. AS PER DOCTOR, A HANDLING OF THE PRODUCT WAS FINE AND THE SITE WAS NOT OVERFILLED BY THE PRODUCT. THE PATIENT HAS NO KNOWN ALLERGIES. DOCTOR REMOVED THE PRODUCT FROM THE SITE. COMPLAINT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    521055 GUIDOR EASY-GRAFT CLASSIC LYC DEGRADABLE SOLUTIONS AG C11-078 15-199 07640164360096

    Patients

    Seq Age Sex Outcome Treatment
    1 Other