BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEMPSPAN TRANSPARENT

    MDR report key: 2851955 · Received November 29, 2012

    Report

    Report Number
    2024312-2012-00311
    Event Type
    Injury
    Date Received
    November 29, 2012
    Report Date
    October 31, 2012
    Manufacturer
    PENTRON CLINICAL
    Product Code
    EMA
    PMA / PMN Number
    K053565
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT SPECIFICS WITH REGARD TO AGE, GENDER, AND WEIGHT WERE NOT PROVIDED BY THE DOCTOR. THE DOCTOR REMOVED THE PATIENT'S TEMPORARY RESTORATION AND CLEANED THE TOOTH. THE PATIENT'S TEMPORARY RESTORATION WAS RE-CEMENTED WITH A DIFFERENT PRODUCT, WITHOUT FURTHER INCIDENT. TO DATE, THE PATIENT IS DOING FINE. THE PRODUCT INVOLVED IN THE ALLEGED INCIDENT WAS NOT RETURNED; THEREFORE, RETAIN SAMPLES WERE EVALUATED YIELDING RESULTS WITHIN SPECIFICATIONS. A DHR REVIEW REVEALED THAT THERE WERE NO DEVIATIONS FROM THE MANUFACTURING PROCESS. IN ADDITION, NO SIMILAR COMPLAINTS WERE RECEIVED WITH REGARD TO THIS LOT.

    Additional Manufacturer Narrative · 1

    A VISUAL INSPECTION WAS PERFORMED ON THE RETURNED SAMPLE, YIELDING RESULTS WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    A DOCTOR ALLEGED THAT A PATIENT EXPERIENCED DARKENING OF THEIR TEETH AFTER USING TEMPSPAN TRANSPARENT TO CEMENT A TEMPORARY RESTORATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TEMPSPAN TRANSPARENT CEMENT, DENTAL EMA PENTRON CLINICAL 3617992

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R