BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY CONDENSABLE

    MDR report key: 409783 · Received August 7, 2002

    Report

    Report Number
    2024312-2002-00001
    Event Type
    Injury
    Date Received
    August 7, 2002
    Date of Event
    February 19, 2001
    Report Date
    July 17, 2002
    Manufacturer
    KERR DENTAL MATERIALS CENTER
    Product Code
    EBF
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    THE LAWSUIT ALLEGED THAT DOCTOR PERFORMED A TOOTH RESTORATION UTILIZING A CAULK GUN WITH PRODIGY CONDENSABLE, DURING THE RESTORATION PROCESS, THE UNIDOSE CAPSULE BROKE APART AND THE FRAGMENTS HIT THE MAXILLARY LEFT LATERAL INCISOR TOOTH. THE TOOTH WAS DIAGNOSED AS HAVING A ROOT FRACTURE. THE TOOTH WAS REMOVED AND REPLACED WITH AN IMPLANT AND CROWN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention