BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO MIR 5MM OVAL CS FS

    MDR report key: 2449877 · Received February 2, 2012

    Report

    Report Number
    2523190-2012-00015
    Event Type
    Malfunction
    Date Received
    February 2, 2012
    Report Date
    February 2, 2012
    Manufacturer
    INTEGRA YORK, PA INC.
    Product Code
    EAX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    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.

    Description of Event or Problem · 1

    ON (B)(6) 2012 THE DENTAL ASSISTANT REPORTED DURING AN APICOECTOMY THE DENTIST WAS USING THE MICRO-MIRROR INSIDE THE PT'S MOUTH. THERE WAS NO PROTECTIVE DEVICE IN PLACE DURING THE PROCEDURE. WHEN THE DENTIST HANDED THE MIRROR BACK TO THE DENTAL ASSISTANT, THE ASSISTANT NOTICED THE MIRROR HEAD WAS MISSING; THERE WAS NO PT INJURY OR ISSUES REPORTED AND THE DENTAL ASSISTANT REPORTED SHE 'ASSUMED THE PT SWALLOWED THE MIRROR".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRO MIR 5MM OVAL CS FS M50 - ENDODONTICS EAX INTEGRA YORK, PA INC.

    Patients

    Seq Age Sex Outcome Treatment
    1