BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5 CS MIRR. FS DOUBLE SIDE

    MDR report key: 1637622 · Received March 16, 2010

    Report

    Report Number
    2523190-2010-00001
    Event Type
    Malfunction
    Date Received
    March 16, 2010
    Date of Event
    February 19, 2010
    Report Date
    March 16, 2010
    Product Code
    EAX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATORS REPORT THE CONDITION OF RETURNED INSTRUMENT AS USED. IT WAS CONFIRMED THAT THE RETURNED MIRROR HAS BOTH SIDES SEPARATED FROM THE FRAME. THERE IS RESIDUAL ADHESIVE ON THE MIRROR FRAME. THE REFLECTIVE SURFACE OF THE GLASS IS SCRATCHED, SPOTTED, AND WORN. THE ROOT CAUSE COULD NOT BE DETERMINED. BASED ON THE REPORTED INFO AND THE INVESTIGATION RESULTS PROVIDED, INTEGRA CONSIDERS THIS COMPLAINT CLOSED. FUTURE INCIDENTS OF THIS NATURE WILL BE DOCUMENTED FOR RECURRENCE AND TRENDING PURPOSES.

    Description of Event or Problem · 1

    DENTAL FACILITY REPORTED THAT ON FRIDAY (B)(6)2010, A (B)(6) CHILD SWALLOWED A MIRROR THAT WAS USED TO RETRACT THE CHEEK/TONGUE DURING A ROUTINE SEALANT PROCEDURE. THE MIRROR FELL OUT OF ITS FRAME. CHILD WAS SENT TO THE URGENT CARE CENTER TO BE EVALUATED. URGENT CARE CENTER ADVISED PARENT TO GO TO THE HOSPITAL EMERGENCY ROOM WHERE THE CHILD WAS SEDATED FOR REMOVAL OF MIRROR FROM THE ESOPHAGUS. DOCTOR CONTACTED THE MOTHER ON SATURDAY (B)(6)2010 TO F/U ON CHILD'S CONDITION. CHILD IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5 CS MIRR. FS DOUBLE SIDE M52 - HYGIENE/PERIDONTAL EAX E46804111

    Patients

    Seq Age Sex Outcome Treatment
    1