BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY CONDENSABLE

    MDR report key: 251414 · Received November 24, 1999

    Report

    Report Number
    2024312-1999-00001
    Event Type
    Injury
    Date Received
    November 24, 1999
    Date of Event
    October 27, 1999
    Report Date
    October 27, 1999
    Manufacturer
    KERR DENTAL MATERIALS CENTER
    Product Code
    EBF
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    THIS REPORT WAS REC'D VIA A DENTIST WHO STATED THE PRODUCT'S TIP BROKE APART. ADD'L INFO REC'D ON 11/22/99 REVEALED THAT THE PT BECAME STARTLED WHEN THE TIP BROKE APART. THE PT DUMPED INTO THE DISPENSING GUN, THUS CHIPPING A TOOTH. THE DENTIST, SUBSEQUENTLY, REPAIRED THE CHIPPED TOOTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRODIGY CONDENSABLE DENTAL COMPOSITE EBF KERR DENTAL MATERIALS CENTER NA 909428

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention