BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIDMARK UNIVERSAL PROCEDURE TABLE

    MDR report key: 22436151 · Received July 8, 2025

    Report

    Report Number
    1523530-2025-00004
    Event Type
    Injury
    Date Received
    July 8, 2025
    Date of Event
    August 29, 2023
    Report Date
    July 8, 2025
    Manufacturer
    MIDMARK CORPORATION
    Product Code
    GBB
    UDI-DI
    00841709106514
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    MIDMARK CORPORATION WAS MADE AWARE ON JUNE 10, 2025, OF AN INCIDENT THAT REPORTEDLY OCCURRED ON OR AROUND (B)(6) 2023, INVOLVING A MIDMARK PROCEDURE CHAIR. ACCORDING TO THE INFORMATION RECEIVED, DURING A MEDICAL PROCEDURE, A PATIENT WAS INSTRUCTED BY STAFF TO REPOSITION THEMSELVES BY TURNING AND LYING ON THEIR STOMACH. UPON DOING SO, THE CHAIR ALLEGEDLY FELL FLAT TO THE GROUND, RESULTING IN THE PATIENT FALLING AS WELL. SUBSEQUENT EVALUATION BY THE PATIENT'S PRIMARY CARE PROVIDER INDICATED THAT THE PATIENT SUSTAINED A SHOULDER INJURY. THE INCIDENT WAS NOT REPORTED TO MIDMARK AT THE TIME IT OCCURRED, AND AS A RESULT, NO PRIOR COMPLAINT IS ON FILE FOR THE INDICATED SERIAL NUMBER OR DEVICE. IF FURTHER INFORMATION IS MADE AVAILABLE, MIDMARK CORPORATION WILL COMPLY WITH A FOLLOW UP REPORT AS NECESSARY.

    Description of Event or Problem · 0

    ON JUNE 10, 2025, MIDMARK CORPORATION WAS NOTIFIED OF AN INSTANCE THAT OCCURRED ON OR AROUND (B)(6) 2023 IN WHICH A MODEL 630 PROCEDURE CHAIR FELL CAUSING THE PATIENT TO FALL TO THE GROUND. DUE TO THE DESCRIPTION OF EVENT AND DUE DILIGENCE, MIDMARK CORPORATION COMPLIED WITH FILING THIS INSTANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2071487 MIDMARK UNIVERSAL PROCEDURE TABLE 630 GBB MIDMARK CORPORATION 630-021 00841709106514

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other