BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVER TOFFLEMIRE TYPE RE

    MDR report key: 5919576 · Received August 31, 2016

    Report

    Report Number
    2523190-2016-00129
    Event Type
    Malfunction
    Date Received
    August 31, 2016
    Date of Event
    June 24, 2016
    Report Date
    August 8, 2016
    Manufacturer
    INTEGRA YORK, PA INC.
    Product Code
    JEP
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Additional Manufacturer Narrative · 1

    ON 9/1/2016 INTEGRA INVESTIGATION COMPLETED. METHOD: FAILURE ANALYSIS, DEVICE HISTORY EVALUATION. RESULTS: FAILURE ANALYSIS: THERE WERE (B)(4) TOFFLEMIRE RETAINERS RETURNED WITH NO UNUSUAL MARKINGS. UPON FURTHER INVESTIGATION IT IS FOUND THAT SOME DO HAVE SHARP EDGES ON THEM. THE COMPLAINT REPORT IS CONFIRMED. DEVICE HISTORY EVALUATION - NONCONFORMING PRODUCT REPORT / NONCONFORMING MATERIAL REPORT HISTORY: THERE IS NO APPLICABLE NONCONFORMING PRODUCT REPORT / NONCONFORMING MATERIAL REPORT HISTORY: VARIANCE AUTHORIZATION / DEVIATION HISTORY: NONE. ENGINEERING CHANGE ORDER/MANUFACTURING CHANGE ORDER HISTORY: THERE IS NO APPLICABLE ENGINEERING CHANGE ORDER/MANUFACTURING CHANGE ORDER HISTORY. CORRECTIVE ACTION PREVENTIVE ACTION HISTORY: (B)(4) ISSUED (B)(6) 2010 FUNCTIONAL ISSUES DURING USE HEALTH HAZARD EVALUATION HISTORY: NONE. CONCLUSION: THE ROOT CAUSE HAS BEEN DETERMINED TO BE A WORKMANSHIP OR MATERIAL DEFICIENCY.

    Description of Event or Problem · 1

    CUSTOMER INITIALLY REPORTS DOCTOR WAS CUT, ITEM DOESN'T WORK WELL. ON (B)(6) 2016 DOCTOR REPORTS SHE WAS CUT THROUGH HER GLOVE BY MATRIX BAND WHEN SHE TRIED TO APPLY IT WITH THE DEVICE. NEEDED TO APPLY A LOT OF PRESSURE. NO HARM DONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570974 UNIVER TOFFLEMIRE TYPE RE M51 - GENERAL DENTISTRY JEP INTEGRA YORK, PA INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR