BEUDAMED
    FDA Adverse Event Summary report: N

    MIDMARK

    MDR report key: 6210796 · Received December 28, 2016

    Report

    Report Number
    1523530-2016-00006
    Date Received
    December 28, 2016
    Date of Event
    November 7, 2016
    Report Date
    December 28, 2016
    Manufacturer
    MIDMARK CORPORTATION
    Product Code
    NRU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL EVENT WAS REVIEWED BY A PARTY OF SUBJECT MATTER EXPERTS INCLUDING QUALITY ENGINEERING, POST MARKET SURVEILLANCE AND CLINICAL AFFAIRS AND DETERMINED TO BE NOT REPORTABLE. THE HEALTH HAZARD EVALUATION BOARD MET TO DISCUSS THE EVENT ON 11/29/2016 AND DETERMINED WITH FURTHER CONSIDERATION THAT THE EXISTING RISK IS TO BE FURTHER EVALUATED AND INCREASED TO A LEVEL REQUIRING REPORTING. THIS EXPLAINS THE INITIAL APPEARANCE OF LATE REPORTING. IT CAN BE NOTED HOWEVER THAT THE 30 DAY REPORTING REQUIREMENT HAS BEEN MET BASED UPON THE FINAL DECISION DATE OF 11/29/2016.

    Description of Event or Problem · 1

    PEDIATRICIAN CONTACTED DISTRIBUTER FROM PATTERSON DENTAL WITH CONCERNS THAT THE 18000 DENTAL CHAIR MAY PRESENT A HAZARD FOR SMALL CHILDREN. IF THE PEDIATRIC PATIENT WEDGES THEIR LEGS BETWEEN THE ARM REST AND THE PROVIDER WHILE THE CHAIR IS RAISED THE LEG MAY ORIENT TO A POSITION THAT COULD RESULT IN INJURY. THIS IS REPORTED AS CONCERN; NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    861131 MIDMARK DENTAL CHAIR NRU MIDMARK CORPORTATION 18000

    Patients

    Seq Age Sex Outcome Treatment
    1