BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIRROR - DBL SIDED, SZ 5

    MDR report key: 2623531 · Received June 15, 2012

    Report

    Report Number
    2523190-2012-00052
    Event Type
    Malfunction
    Date Received
    June 15, 2012
    Report Date
    June 15, 2012
    Manufacturer
    MILTEX, INC.
    Product Code
    EAX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO.

    Description of Event or Problem · 1

    MIRRORS POPPED OUT. NO PT INJURY. ON (B)(6) 2012, CUSTOMER REPORTS THE PT COULD HAVE SWALLOWED THE MIRRORS, BUT DID NOT. THE CUSTOMER WAS UNABLE TO SINGLE OUT A PARTICULAR PT OR PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MIRROR - DBL SIDED, SZ 5 M52 - HYGIENE / PERIODONTAL EAX MILTEX, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1