BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLOW-IT

    MDR report key: 4665397 · Received April 7, 2015

    Report

    Report Number
    2024312-2015-00009
    Event Type
    Injury
    Date Received
    April 7, 2015
    Report Date
    March 11, 2015
    Manufacturer
    PENTRON CLINICAL
    Product Code
    EBF
    PMA / PMN Number
    K952662
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    SPECIFIC PATIENT INFORMATION WITH REGARD TO AGE AND WEIGHT WAS NOT PROVIDED BY THE DOCTOR. ALTHOUGH THE DOCTOR IDENTIFIED TWO (2) DIFFERENT LOT NUMBERS ASSOCIATED WITH BUBBLES, HE COULD NOT VERIFY WHICH LOT WAS USED ON THE PATIENT; THEREFORE, NO LOT NUMBERS WERE IDENTIFIED IN THIS REPORT. THE LOT NUMBERS INVOLVED IN THE ALLEGED INCIDENT INCLUDE 5089748 AND 5183433. THE DOCTOR DRILLED OUT THE COMPOSITE AND REPLACED IT. TO DATE, THE PATIENTS ARE DOING FINE. THE PRODUCTS INVOLVED IN THE ALLEGED INCIDENT WERE RETURNED. RETURNED SAMPLES FROM THE EACH OF THE REPORTED LOTS WERE EVALUATED, YIELDING RESULTS WITHIN SPECIFICATIONS. A DHR REVIEW INDICATED THAT THERE WERE NO DEVIATIONS FROM THE MANUFACTURING PROCESS. IN ADDITION, NO SIMILAR COMPLAINTS WERE RECEIVED WITH REGARD TO THESE LOTS.

    Description of Event or Problem · 1

    A DOCTOR ALLEGED THAT BUBBLES WERE PRESENT AFTER PLACEMENT OF FLOW IT FOR MULTIPLE PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    229589 FLOW-IT TOOTH SHADE RESIN MATERIAL EBF PENTRON CLINICAL N11B

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R