BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRADENT ULTRACAL XS CALCIUM HYDROXIDE PASTE

    MDR report key: 9208114 · Received October 17, 2019

    Report

    Report Number
    MW5090472
    Event Type
    Injury
    Date Received
    October 17, 2019
    Date of Event
    May 29, 2019
    Report Date
    October 3, 2019
    Manufacturer
    ULTRADENT PRODUCTS, INC. / ORATECH LLC
    Product Code
    EJK
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2019, MY ENDODONTIST OVERFILLED THE ROOT CANAL OF TOOTH #19 WITH CALCIUM HYDROXIDE RESULTING IN PERSISTENT ANESTHESIA AND DYSESTHESIA. ON (B)(6) 2019, (B)(6), DDS, MD SURGICALLY REMOVED PORTIONS OF THE CALCIUM HYDROXIDE OVERFILL WHICH HAD MUMMIFIED MY MANDIBULAR NERVE; TREATMENT RECORDS OF THE FOLLOWING: RECORDS-AND (B)(6) 2019 PANOREX X-RAY OF ENDODONTIST, (B)(6), DDS, MD'S SURGICAL REPORT, (B)(6) CBCT DATED (B)(6) 2019, TREATMENT RECORD OF THE ENDODONTIST'S CALCIUM HYDROXIDE OVERFILL INCLUDING RADIOGRAPH DATED (B)(6) 2019, SURGICAL RECORD OF DR (B)(6). NO MEDICATIONS FOR PERSISTENT ANESTHESIA OF MY LEFT LIP, CHIN, AND GUMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    999868 ULTRADENT ULTRACAL XS CALCIUM HYDROXIDE PASTE LINER, CAVITY / CALCIUM HYDROXIDE EJK ULTRADENT PRODUCTS, INC. / ORATECH LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other| S