BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIDMARK

    MDR report key: 4264886 · Received October 31, 2014

    Report

    Report Number
    1523530-2014-00017
    Event Type
    Injury
    Date Received
    October 31, 2014
    Date of Event
    October 2, 2014
    Report Date
    October 31, 2014
    Manufacturer
    MIDMARK CORP.
    Product Code
    NRU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE MIDMARK ULTRA CHAIR MOVEMENT IS CONTROLLED BY THE OPERATOR. PATIENTS ARE TRANSITIONING INTO A NON-SEATED POSITION WHILE THE CHAIR IS MOVING. THIS WAS EXPLAINED TO THE END USER.

    Description of Event or Problem · 1

    PATIENT HAVE BEEN GETTING THEIR LEGS CAUGHT BETWEEN THE CHAIRS SEAT AND ARMREST. INJURY DESCRIBED AS COMPRESSION WITH NO BROKEN BONES OR LACERATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    699496 MIDMARK CHAIR, DENTAL, WITHOUT OPERATIVE UNI NRU MIDMARK CORP. 153592

    Patients

    Seq Age Sex Outcome Treatment
    1 Other