BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLOW-IT

    MDR report key: 3738224 · Received April 10, 2014

    Report

    Report Number
    2024312-2014-00185
    Event Type
    Injury
    Date Received
    April 10, 2014
    Report Date
    March 12, 2014
    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

    ALTHOUGH THE DOCTOR IDENTIFIED SIXTEEN (16) DIFFERENT SHADES ASSOCIATED WITH THE VOIDS, HE COULD NOT VERIFY WHICH LOT WAS USED ON EACH PATIENT; THEREFORE, NO LOT NUMBERS WERE IDENTIFIED. THE LOTS INVOLVED IN THE ALLEGED INCIDENTS INCLUDE LOT NUMBERS 4993573, 5071956, 3646018, 4652388, 4981292, 4552909, 4268918, 4873383, 4602576, 4330005, 4629825, 3566441, 4758120, 4754648, 4119565, 4758128, 4880060, 4775993, 4911506, 4119569, 4939389, 5005302, 4546880, 4759763, 470273, 4980561, AND 4633363. PATIENTS SPECIFICS WITH REGARD TO GENDER, AGE AND WEIGHT WERE NOT PROVIDED BY THE DOCTOR. IT WAS REPORTED THAT THE DOCTOR DRILLED OUT THE COMPOSITE AND REPEATED THE PROCEDURES, WITHOUT FURTHER INCIDENT. TO DATE, THE PATIENTS ARE DOING FINE. AN EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN.

    Additional Manufacturer Narrative · 1

    THE PRODUCTS WERE RETURNED AND 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 THESE LOTS.

    Description of Event or Problem · 1

    A DOCTOR'S OFFICE ALLEGED THAT VOIDS WERE SEEN WITHIN MULTIPLE PATIENTS RESTORATIONS AFTER LIGHT CURING FLOW-IT COMPOSITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219011 FLOW-IT TOOTH SHADE RESIN MATERIAL EBF PENTRON CLINICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R