BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIDMARK ULTRA TRIM DENTAL CHAIR

    MDR report key: 17790004 · Received September 21, 2023

    Report

    Report Number
    1523530-2023-00005
    Event Type
    Malfunction
    Date Received
    September 21, 2023
    Date of Event
    August 21, 2023
    Report Date
    September 21, 2023
    Manufacturer
    MIDMARK CORPORATION
    Product Code
    NRU
    UDI-DI
    00841709108976
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    THIS REPORT SUMMARIZES AN EVENT THAT WAS REPORTED TO MIDMARK ON (B)(6), 2023 IN WHICH IT WAS STATED THAT THE BACK OF A DENTAL CHAIR DETACHED FROM THE BASE WITH A PATIENT IN THE CHAIR. NO INJURY WAS REPORTED. PER SERVICE NOTE, THE SHOULDER BOLTS THAT HOLD THE BACKREST, AT THE SIDE OF THE CHAIR, BEHIND THE TOUCH PAD CONTROLS APPEARED LOOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1584762 MIDMARK ULTRA TRIM DENTAL CHAIR ULTRA TRIM DENTAL CHAIR NRU MIDMARK CORPORATION 153758-003 00841709108976

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other