BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BREEZE SE CEMENT

    MDR report key: 2133013 · Received June 17, 2011

    Report

    Report Number
    2024312-2011-00192
    Event Type
    Injury
    Date Received
    June 17, 2011
    Report Date
    May 17, 2011
    Manufacturer
    PENTRON CLINICAL
    Product Code
    EMA
    PMA / PMN Number
    K060698
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    CROWN CAME OFF WHEN DOCTOR WAS CLEANING OFF EXCESS MATERIAL. CROWN WAS RECEMENTED WITH ANOTHER SYRINGE OF BREEZE WITHOUT FURTHER INCIDENT. PER DOCTOR, THE SYRINGE USED WAS NOT REFRIGERATED AS INDICATED IN THE IFU. NO PRESCRIPTION MEDICATION WAS REQUIRED TO TREAT THE PATIENT. PRODUCT WAS RETURNED BY THE CUSTOMER AS WELL AS A RETAIN SAMPLE WAS EVALUATED FOR GEL SET TIME MET PRODUCT SPECIFICATIONS. A REVIEW OF THE DHR INDICATED THAT THERE WERE NO NON-CONFORMANCE OR VARIANCES IN THE MANUFACTURING PROCESS. A REVIEW OF COMPLAINT DATABASE TRENDING INDICATED THERE WERE NOT SIMILAR COMPLAINTS RECEIVED FOR THIS LOT. THESE INVESTIGATION RESULTS INDICATED THAT THIS INCIDENT WAS NOT THE RESULT OF PRODUCT FAILURE AND MAY BE RELATED TO THE PRODUCT NOT BEING REFRIGERATED AS INDICATED IN THE IFU.

    Description of Event or Problem · 1

    ON (B)(6) 2011 A DOCTOR REPORTED THAT A CROWN THAT HAD BEEN PLACED WITH BREEZE SE CEMENT DE-BONDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BREEZE SE CEMENT DENTAL CEMENT EMA PENTRON CLINICAL 183843

    Patients

    Seq Age Sex Outcome Treatment
    1 Other