BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIDMARK

    MDR report key: 3952023 · Received July 16, 2014

    Report

    Report Number
    1523530-2014-00012
    Event Type
    Injury
    Date Received
    July 16, 2014
    Date of Event
    June 16, 2014
    Report Date
    July 15, 2014
    Manufacturer
    MIDMARK CORP.
    Product Code
    NRU
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVAL OF THE CHAIR WAS DONE ON-SITE AND A REVIEW WAS CONDUCTED AT OUR FACILITY OF A COMPARABLE LOT. THE CHAIR DESIGN WAS REVIEWED FOR COMPLIANCE TO APPLICABLE SAFETY STANDARDS AND WAS FOUND TO BE IN COMPLIANCE. THE RISK MANAGEMENT FILE WAS REVIEWED AND FOUND TO HAVE ISSUE TO BE EVALUATED. THE FAILURE THAT OCCURRED HAS BEEN DETERMINED TO BE RELATED TO FAILURE TO FOLLOW USER MANUAL GUIDANCE.

    Description of Event or Problem · 1

    A DENTIST REPORTED THAT A PARENT WAS SEATED SIDEWAYS ON THE CHAIR WITH CHILD, WHO WAS THE PT, ON HIS LAP WHEN THE MIDMARK ELEVANCE DENTAL CHAIR WAS COMMENDED TO MOVE. THE PARENT'S LEG WAS PINCHED IN THE GAP BETWEEN THE CHAIR SEAT AND THE BACK. NO MEDICAL INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415899 MIDMARK ELEVANCE DENTAL CHAIR NRU MIDMARK CORP. 153810

    Patients

    Seq Age Sex Outcome Treatment
    1